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Drug Recalls
8 8o
Drug Recalls
The following data have been compiled from the Federa~ Food and Drug Administration Weekly Recall Reports covering the period December 16, 1969, to January 19; 1970. Pharmacists and others possessing drug inventories are reminded to check their stock again to be certain that they do not have any of the products on this list. Anyone who has additional facts on any of the listed recalls which he feels will assist in completing the recall is urged to send such data to the editor of this Journal.
Product
. Firm identified on Product Label
Dome Aminet suppositories full strength (aminophylline (West Haven, Conn.) USP 500 mg, pentobarbital sodium USP 100 mg benzoca iiw N F 60 mg) Rugby Aminophylline USP 11/2 gr with .phenobarbital USP 1/4 (Inwood, N.Y.) grtablets, 1,000's Henry Schein (Flushing, N.Y.) Analexin (in each 5 ml: Neisler phenyrahlidol salicylate (Decatur, III.) 100 mg) syrup, pints and gallons Analexin (phenyramidol Neisler hydrochloride 200 mg) (Decatur, III.) tablets, 100's and 500's Analexin·400 (phenyramidol Neisler hydrochloride 400 mg) ([)ecatur, ilL) capsules, 50's and 500's Analexin·AF (phenyramidol Neisler hydrochloride 100 mg, (Decatur, III.) aluminum aspirin 300 mg) tablets, 100's and 500's Standard Aspirin (acetylsalicylic (Elgin, ilL) acid USP 5 gr) enteric coated tablets, 100's Blutene chloride (tolonium chloride ~OO mg) tablets, 25's and 100's Chorionic gonadotropin 10,000 I.U., 10 ml vial with diluent
Abbott (N. Chicago, III.)
Bel·Air (Los Angeles, Calif.) Bel-Mar (Inwood, N.Y.) Daylin (Los Angeles, Calif.) Fox (Carthage, N.Y.) Generix (Hollywood, Fla.) Rugby (Inwood, N.Y.) Spencer-Mead (Valley Steram, N.Y.) Merck Sharp and Dohme Decadron (dexamethasone sodium phosphate NF 1%) (West Point, Pa.) ophthalmic solution, 2.5 ml and 5 ml
Lot Number
. Quantity
0027106
9,852 suppositories
3639
357,000 tablets
All lots
180 gallons
All lots
270,000 tablets
All lots
438,000 capsules
All lots
538,000 tablets
0867, 1252 1370, 1473 2193, 2344 2417
6,106;000 tablets
All lots
18,795.150 tablets
6931
9,420 vials
All lots with suffix letters preceding
26,000-2.5 ml 116,000-5 ml
M Digoxin USP 0.25 mg tablets, 1,000'5 and 5,000's
Spencer-Mead (Valley Stream, N.Y.) Vita-Fore (Ozone Park, N.Y.)
14624
400,000 tablets
Digoxin USP 0.25 mg tablets, 1,000'5, 5,OOO's and bulk
AmeriCan Quinine (Plainview, N.Y.) Davis-Edwards (Danbury, Conn.) Hillco (Santa Fe Springs, Calif.) Michigan Pharmacal (Detroit, Mich.) Revco Drug Stores (Cleveland, Ohio) Henry Schein (Flushing, N.Y.) C.O. Truxton (Camden, N.J.) Wolins (Farmingdale, N.Y.)
25776, 25777 , 25840
8,600,000 tablets
Recall Reason
Product Distribution
Mislabeled (some packages labeled 500 mg contain 250 mg) Superpotent (108-113% of declared potencies) Drug efficacy study implementation
Illinois
Drug efficacy study implementation Drug efficacy study implementation Drug efficacy study im pleme ntation
National
Fail USP disintegration tests; excess free salicylic acid Drug efficacy study implementation Subpotent (64% of declared potency)
National
Some lots lose potency prior to expiration date Potency (76.0-134.4% of declared potency); fail USP content uniformity requirements Fail USP content uniformity requirements
Nationai
New York
National
National National
National National
New York
National Canada
Vol. NS10. No. 3, March 1970
183
Product
Fi rm Identified on Product Label
Lot Number
Quantity
Recall Reason
Product Distribution
Digoxin USP 0.25 mg tablets, 1,000's, 5,000's and 6,000's
Dumont (Philadelphia, Pa.) United Research (Philadelphia, Pa.)
41804
2,439,000 tablets
Superpotent; failed USP weight variation requirements (118.8% of declared weight)
National
Digoxin USP 0.25 mg tablets, 1,000's
Barry Martin (Miami, Fla.)
14096
61,000 tablets
Fail USP content uniformity
Alabama Florida Georgia North Carolina South Carolina Tennessee
Ennade (in each 15 ml: pentylenetetrazol NF 100 mg, nicotinic acid NF 50 mg, thiamine hydrochloride USP 2 mg, alcohol 20%) elixir, pints and gallons
Palmedico (Columbia, S.C.)
6511016
484 pints, 18 gallons
Subpotent (10-50% of declared potencies of vitamin components)
Georgia North Carolina South Carolina Tennessee
Ipecac syrup USP, pints
Lilly (Indianapolis, Ind.)
16,032 2NT40B,3BS08B pints 3BS08A, 3EU62A 3FS78A, 3H L67 A
Alkaloid ratio in some lots affecting emetic effectiveness
National
locortar cream (hydrocortisone USP 1/ 4%, iodochlorhydroxyquin USP 3%, coal tar solution USP 3%),loz
Doak (Westbury, N.Y.)
All lots
Superpotent (126-132% of declared hydrocortisone)
Con necticut Indiana Massachusetts New Jersey New York Rhode Island
Meperidine hydrochloride injection NF 25 mg, 50 mg, 75 mg and 100 mg/ml, 1 ml, 25's and 100's
Intra (Dayton, Ohio)
25 mg: 7009, 7045, 4,770,000 7308, 7441, 8023, vials 809050 mg: 7005 , 7006, 7027, 7028, 7138,7181, 7182, 7195-7202, 7305-7307, 7417, 7442, 7443, 7461, 7462, 8024-8030, 8091-8098, 8352, 8446-8449, 8497, 849975 mg: 7007, 7008, 7050, 7051, 7187, 7188, 7313, 7435-7438, 7470, 8032-8035, 8099-8102, 8450, 8451, 8483, 8500, 8501100 mg: 7010, 7011, 7029, 7030, 7185, 72757278, 7439, 7440, 7463, 7469, 80368041, 8103-8108, 9017
Crystallization in some vials
National
Methenamine mandelate U SP enteric coated tablets 1.0 gm, 100's, 500's and l,OOO's
Generix (Hollywood, Fla.)
14585
10,000 tablets
Fail USP disintegration tests
Florida
Nitroglycerine sublingual tablets USP 1/100 gr, 1,000's
Haberle (Montclair, N.J.)
F779
81,000 tablets
Delayed disintegration
Pennsylva nia
Nuporals lozenges (dibucaine hydrochloride USP 1 mg), 15's and 100's
Ciba (Summit, N.J.)
All lots
2,987,500 lozenges
Bacterial contamination (coliforms)
National
Oxytetracycline hydrochloride NF 250 mg capsules, all package sizes
Aetna (Englewood, N.J.) Barre (Baltimore, Md.) Barry Martin (Miami, Fla.) Bates (Chicago, III.) Columbia (New York, N.Y.) Direct (Buffalo, N.Y.) Generic (Brooklyn, N.Y.) Halsey (Brooklyn, N.Y.) Jabert (Freeport, N.Y.) McKesson (Fairfield, Conn.) Moore Kirk (East Woodstock, Conn.)
Q7 through Q9, 16,536,932 Q13 through capsules Q18, 7H-674, 7H-678,7H-704, 7H-737,7H·748, 7H-790, 7H·825, 7H-881, 716, 717, 719, 2421-01 through 2421-10, 8312, 9307 through 9309, 9313/1, 10498, 10646 through 10647, 10770 through 10786, 13490 through 13498, 13771, 13784, 13785, 14215, 14216 14271, 14891, 15182, 15183, 15184, 15481,
Decertified due to failure to produce satisfactory blood levels
National
(continued on page 185) 184
Journal of the AMERICAN PHARMACEUTICAL ASSOCIATION
97 tubes
-
Product
Firm Identified on Product Label
oxytetracycline hydrochloride
Paramount (Brooklyn, N.Y.) (continued from page 184) Penhurst (Philadelphia, Pa.) Purepac (Elizabeth, N.J.) Robinson (Sa n Fra ncisco, Calif.) Rugby (Inwood, N.Y.) Schlicksup (Peoria, III.) Trent (New York, N.Y.) Tutag (Detroit, Mich.) United Research (Philadelphia, Pa.) Wolins (Farmingdale, N.Y.) Zenith (Englewood, N.J.)
Lot Number
Quantity
Recall Reason
Product Distribution
15483
Pen-Tabs (potassium penicillin G USP 250,000 units buffered with calcium carbonate) tablets, 100's
Rexall (St. Louis, Mo.)
9972 VH
406 ,400 tablets
Foreign tablets believed to be 400,000 units co-mi':lgled
National
Phenaco{l capsules (phenylpropa nolamine hydrochloride 25 mg, chlorpheniramine maleate USP 4 mg, salicylamide NF 500 mg, ascorbic acid USP. 50 mg, calcium carbomate 150 mg), 4's, 100's, 500's
Dunhall (Gravette, Ark.)
ME7007C
65,000 capsules
Subpotent (79% of declared ascorbic acid)
Arkansas Missouri Oklahoma Texas
Sinaxar tablets (styramate 200 mg), 50's
Armour (Chicago, III.)
All lots
37,000,000 tablets
Dru,g efficacy study implementation
National South America
Sodium diphenylhydantoin capsules USP 0.1 gm, 100's and I,OOO's
Davis-Edwards (Danbury, Conn.) Interstate (Plainview, N.Y.) Sherry (Long Island City, N.Y.) Spencer-Mead (Valley Stream, N.Y.)
25624
444,000 capsules
Poor manufacturing practices and possible crosscontamination
New York Pennsylvania
All lots
60,000 tablets
Drug efficacy study implementation
National
Sulfathiazole 0. 5 gm tablets, Premo (Hackensack, N.J.) 100' san d I, 000' s Thyroid 1 gr tablets U S P, 1, 000' s
Supreme (Jersey City, N.J.)
B714585, 2923597
409,000 tablets
Superpotent (0 . 245-0.256% iodine instead of 0.17-0.23% U SP limits)
Alabama Arkansas Iowa Massachusetts Missouri New Jersey New York Pennsylvania Texas Wisconsin Virginia
Terramycin dental cones (oxytetracycline hydroch loride N F 5 mg, tetracaine hydrochloride USP 1 mg), 100's
Pfizer (New York, N.Y.)
All lots
All since 1955
Drug efficacy study implementation
Nationa!
" '-
Spartan Two Barbital 3 gr (secobarbital sodium USP (Jersey City, N.J.) 11/2 gr, amobarbital sodium USP 1 1/2 gr), 100's and l,OOO's
1923701
33,600 capsules
Subpotent (73.3% of declared mobarbita I); fail USP weight variation tests
Illinois Kentucky Missouri New York
Illinois
a
Trol-Kol liquid (in each 10 ml: glyceryl guiacolate 100 mg chlorpheniramine maletate USP 7.5 mg phenylephrine hydrochloride USP 9 mg), 16 oz and 1 gallon
Nova (Quincey, "I.)
6398
l,7920z
Subpotent (68% of declared glyceryl gujacolate)
Vanquish tablets (aspirin 227 mg, acetaminophen NF 194 mg, caffeine USP 33 mg, dried aluminum hydroxide gel NF 25 mg, magnesium hydroxide NF 50 mg), 30's
Glenbrook (New York, N.Y.)
All lots distributed by firm's Dallas warehouse
No estimate
Discoloration, odor, crystal growth
Arkansas Kansas New Mexico Oklahoma Texas
Vol. NSI0, No.3, March 1970
185
Drug Recalls
The following data have been compiled from the Federa~ Food and Drug Administration Weekly Recall Reports covering the period December 16, 1969, to January 19; 1970. Pharmacists and others possessing drug inventories are reminded to check their stock again to be certain that they do not have any of the products on this list. Anyone who has additional facts on any of the listed recalls which he feels will assist in completing the recall is urged to send such data to the editor of this Journal.
Product
. Firm identified on Product Label
Dome Aminet suppositories full strength (aminophylline (West Haven, Conn.) USP 500 mg, pentobarbital sodium USP 100 mg benzoca iiw N F 60 mg) Rugby Aminophylline USP 11/2 gr with .phenobarbital USP 1/4 (Inwood, N.Y.) grtablets, 1,000's Henry Schein (Flushing, N.Y.) Analexin (in each 5 ml: Neisler phenyrahlidol salicylate (Decatur, III.) 100 mg) syrup, pints and gallons Analexin (phenyramidol Neisler hydrochloride 200 mg) (Decatur, III.) tablets, 100's and 500's Analexin·400 (phenyramidol Neisler hydrochloride 400 mg) ([)ecatur, ilL) capsules, 50's and 500's Analexin·AF (phenyramidol Neisler hydrochloride 100 mg, (Decatur, III.) aluminum aspirin 300 mg) tablets, 100's and 500's Standard Aspirin (acetylsalicylic (Elgin, ilL) acid USP 5 gr) enteric coated tablets, 100's Blutene chloride (tolonium chloride ~OO mg) tablets, 25's and 100's Chorionic gonadotropin 10,000 I.U., 10 ml vial with diluent
Abbott (N. Chicago, III.)
Bel·Air (Los Angeles, Calif.) Bel-Mar (Inwood, N.Y.) Daylin (Los Angeles, Calif.) Fox (Carthage, N.Y.) Generix (Hollywood, Fla.) Rugby (Inwood, N.Y.) Spencer-Mead (Valley Steram, N.Y.) Merck Sharp and Dohme Decadron (dexamethasone sodium phosphate NF 1%) (West Point, Pa.) ophthalmic solution, 2.5 ml and 5 ml
Lot Number
. Quantity
0027106
9,852 suppositories
3639
357,000 tablets
All lots
180 gallons
All lots
270,000 tablets
All lots
438,000 capsules
All lots
538,000 tablets
0867, 1252 1370, 1473 2193, 2344 2417
6,106;000 tablets
All lots
18,795.150 tablets
6931
9,420 vials
All lots with suffix letters preceding
26,000-2.5 ml 116,000-5 ml
M Digoxin USP 0.25 mg tablets, 1,000'5 and 5,000's
Spencer-Mead (Valley Stream, N.Y.) Vita-Fore (Ozone Park, N.Y.)
14624
400,000 tablets
Digoxin USP 0.25 mg tablets, 1,000'5, 5,OOO's and bulk
AmeriCan Quinine (Plainview, N.Y.) Davis-Edwards (Danbury, Conn.) Hillco (Santa Fe Springs, Calif.) Michigan Pharmacal (Detroit, Mich.) Revco Drug Stores (Cleveland, Ohio) Henry Schein (Flushing, N.Y.) C.O. Truxton (Camden, N.J.) Wolins (Farmingdale, N.Y.)
25776, 25777 , 25840
8,600,000 tablets
Recall Reason
Product Distribution
Mislabeled (some packages labeled 500 mg contain 250 mg) Superpotent (108-113% of declared potencies) Drug efficacy study implementation
Illinois
Drug efficacy study implementation Drug efficacy study implementation Drug efficacy study im pleme ntation
National
Fail USP disintegration tests; excess free salicylic acid Drug efficacy study implementation Subpotent (64% of declared potency)
National
Some lots lose potency prior to expiration date Potency (76.0-134.4% of declared potency); fail USP content uniformity requirements Fail USP content uniformity requirements
Nationai
New York
National
National National
National National
New York
National Canada
Vol. NS10. No. 3, March 1970
183
Product
Fi rm Identified on Product Label
Lot Number
Quantity
Recall Reason
Product Distribution
Digoxin USP 0.25 mg tablets, 1,000's, 5,000's and 6,000's
Dumont (Philadelphia, Pa.) United Research (Philadelphia, Pa.)
41804
2,439,000 tablets
Superpotent; failed USP weight variation requirements (118.8% of declared weight)
National
Digoxin USP 0.25 mg tablets, 1,000's
Barry Martin (Miami, Fla.)
14096
61,000 tablets
Fail USP content uniformity
Alabama Florida Georgia North Carolina South Carolina Tennessee
Ennade (in each 15 ml: pentylenetetrazol NF 100 mg, nicotinic acid NF 50 mg, thiamine hydrochloride USP 2 mg, alcohol 20%) elixir, pints and gallons
Palmedico (Columbia, S.C.)
6511016
484 pints, 18 gallons
Subpotent (10-50% of declared potencies of vitamin components)
Georgia North Carolina South Carolina Tennessee
Ipecac syrup USP, pints
Lilly (Indianapolis, Ind.)
16,032 2NT40B,3BS08B pints 3BS08A, 3EU62A 3FS78A, 3H L67 A
Alkaloid ratio in some lots affecting emetic effectiveness
National
locortar cream (hydrocortisone USP 1/ 4%, iodochlorhydroxyquin USP 3%, coal tar solution USP 3%),loz
Doak (Westbury, N.Y.)
All lots
Superpotent (126-132% of declared hydrocortisone)
Con necticut Indiana Massachusetts New Jersey New York Rhode Island
Meperidine hydrochloride injection NF 25 mg, 50 mg, 75 mg and 100 mg/ml, 1 ml, 25's and 100's
Intra (Dayton, Ohio)
25 mg: 7009, 7045, 4,770,000 7308, 7441, 8023, vials 809050 mg: 7005 , 7006, 7027, 7028, 7138,7181, 7182, 7195-7202, 7305-7307, 7417, 7442, 7443, 7461, 7462, 8024-8030, 8091-8098, 8352, 8446-8449, 8497, 849975 mg: 7007, 7008, 7050, 7051, 7187, 7188, 7313, 7435-7438, 7470, 8032-8035, 8099-8102, 8450, 8451, 8483, 8500, 8501100 mg: 7010, 7011, 7029, 7030, 7185, 72757278, 7439, 7440, 7463, 7469, 80368041, 8103-8108, 9017
Crystallization in some vials
National
Methenamine mandelate U SP enteric coated tablets 1.0 gm, 100's, 500's and l,OOO's
Generix (Hollywood, Fla.)
14585
10,000 tablets
Fail USP disintegration tests
Florida
Nitroglycerine sublingual tablets USP 1/100 gr, 1,000's
Haberle (Montclair, N.J.)
F779
81,000 tablets
Delayed disintegration
Pennsylva nia
Nuporals lozenges (dibucaine hydrochloride USP 1 mg), 15's and 100's
Ciba (Summit, N.J.)
All lots
2,987,500 lozenges
Bacterial contamination (coliforms)
National
Oxytetracycline hydrochloride NF 250 mg capsules, all package sizes
Aetna (Englewood, N.J.) Barre (Baltimore, Md.) Barry Martin (Miami, Fla.) Bates (Chicago, III.) Columbia (New York, N.Y.) Direct (Buffalo, N.Y.) Generic (Brooklyn, N.Y.) Halsey (Brooklyn, N.Y.) Jabert (Freeport, N.Y.) McKesson (Fairfield, Conn.) Moore Kirk (East Woodstock, Conn.)
Q7 through Q9, 16,536,932 Q13 through capsules Q18, 7H-674, 7H-678,7H-704, 7H-737,7H·748, 7H-790, 7H·825, 7H-881, 716, 717, 719, 2421-01 through 2421-10, 8312, 9307 through 9309, 9313/1, 10498, 10646 through 10647, 10770 through 10786, 13490 through 13498, 13771, 13784, 13785, 14215, 14216 14271, 14891, 15182, 15183, 15184, 15481,
Decertified due to failure to produce satisfactory blood levels
National
(continued on page 185) 184
Journal of the AMERICAN PHARMACEUTICAL ASSOCIATION
97 tubes
-
Product
Firm Identified on Product Label
oxytetracycline hydrochloride
Paramount (Brooklyn, N.Y.) (continued from page 184) Penhurst (Philadelphia, Pa.) Purepac (Elizabeth, N.J.) Robinson (Sa n Fra ncisco, Calif.) Rugby (Inwood, N.Y.) Schlicksup (Peoria, III.) Trent (New York, N.Y.) Tutag (Detroit, Mich.) United Research (Philadelphia, Pa.) Wolins (Farmingdale, N.Y.) Zenith (Englewood, N.J.)
Lot Number
Quantity
Recall Reason
Product Distribution
15483
Pen-Tabs (potassium penicillin G USP 250,000 units buffered with calcium carbonate) tablets, 100's
Rexall (St. Louis, Mo.)
9972 VH
406 ,400 tablets
Foreign tablets believed to be 400,000 units co-mi':lgled
National
Phenaco{l capsules (phenylpropa nolamine hydrochloride 25 mg, chlorpheniramine maleate USP 4 mg, salicylamide NF 500 mg, ascorbic acid USP. 50 mg, calcium carbomate 150 mg), 4's, 100's, 500's
Dunhall (Gravette, Ark.)
ME7007C
65,000 capsules
Subpotent (79% of declared ascorbic acid)
Arkansas Missouri Oklahoma Texas
Sinaxar tablets (styramate 200 mg), 50's
Armour (Chicago, III.)
All lots
37,000,000 tablets
Dru,g efficacy study implementation
National South America
Sodium diphenylhydantoin capsules USP 0.1 gm, 100's and I,OOO's
Davis-Edwards (Danbury, Conn.) Interstate (Plainview, N.Y.) Sherry (Long Island City, N.Y.) Spencer-Mead (Valley Stream, N.Y.)
25624
444,000 capsules
Poor manufacturing practices and possible crosscontamination
New York Pennsylvania
All lots
60,000 tablets
Drug efficacy study implementation
National
Sulfathiazole 0. 5 gm tablets, Premo (Hackensack, N.J.) 100' san d I, 000' s Thyroid 1 gr tablets U S P, 1, 000' s
Supreme (Jersey City, N.J.)
B714585, 2923597
409,000 tablets
Superpotent (0 . 245-0.256% iodine instead of 0.17-0.23% U SP limits)
Alabama Arkansas Iowa Massachusetts Missouri New Jersey New York Pennsylvania Texas Wisconsin Virginia
Terramycin dental cones (oxytetracycline hydroch loride N F 5 mg, tetracaine hydrochloride USP 1 mg), 100's
Pfizer (New York, N.Y.)
All lots
All since 1955
Drug efficacy study implementation
Nationa!
" '-
Spartan Two Barbital 3 gr (secobarbital sodium USP (Jersey City, N.J.) 11/2 gr, amobarbital sodium USP 1 1/2 gr), 100's and l,OOO's
1923701
33,600 capsules
Subpotent (73.3% of declared mobarbita I); fail USP weight variation tests
Illinois Kentucky Missouri New York
Illinois
a
Trol-Kol liquid (in each 10 ml: glyceryl guiacolate 100 mg chlorpheniramine maletate USP 7.5 mg phenylephrine hydrochloride USP 9 mg), 16 oz and 1 gallon
Nova (Quincey, "I.)
6398
l,7920z
Subpotent (68% of declared glyceryl gujacolate)
Vanquish tablets (aspirin 227 mg, acetaminophen NF 194 mg, caffeine USP 33 mg, dried aluminum hydroxide gel NF 25 mg, magnesium hydroxide NF 50 mg), 30's
Glenbrook (New York, N.Y.)
All lots distributed by firm's Dallas warehouse
No estimate
Discoloration, odor, crystal growth
Arkansas Kansas New Mexico Oklahoma Texas
Vol. NSI0, No.3, March 1970
185