Drug Recalls

8

Drug Recalls 8o

The following data have been compiled from the Federal Food and Drug Administration Weekly, Recall Rep ? rts covering ~he period April 23, 1970, ~ May 20, 1970 , Pharmacists and oth ers p ossessing drug inventories are reminded to check t~elr stock agm,n to ~ e ,certam th~t the y do not, have any of the products on this list, Anyone w ho has additional facts on any of the listed recalls whlch h e feels w lll asslst m completmg th e re call 18 urged to send such data to the editor of this Journal Product Blud ex tim e d disintegration ca psules (d-amphetamine hydrochloride 15 mg, amobarbital USP 60 mg), all sizes Chorionic gonadotropin injection 5 , 000 I.U./ml, 5 ml

Delfeta-Sed Plus T steadytabs sustained release tablets (dl -methamphetamine hydrochloride USP 30 mg, amobarbital USP 120 mg, thyroid US P 48.6 m g) , 30's Dext roamphetamine sulfate timed release capsules 15 m g , 1,000' s and 5,000's

Digoxin tablets USP 0.25 mg, 100' s, 1,000's and 5,000's Digox in tablets USP 0.25 mg, 1,000' s and 5,000's

Firm Identified on Prod uct Label Bluco (Detroit, Mich_)

Band B (Los Angeles, Calif.) Bel -Mar (Inwood, N.Y_) Bio-Intrasol (Brooklyn, N.Y.) Moore-Kirk (H illside, N.J.) Rugby (Inwood, N.Y.) Scientific Surgical (Sherman Oaks, Calif.) John F. Hancock (Baltimore , Md.)

Bel -Air (Los Angeles, Calif.) Garden (Hackensack, N.J.) Sherry (Bay Shore, N_Y.) Davies-Rose Hoyt (Needham, Mass.)

Cooper (Detroit, Mich.) Paramount ' (Northvale, N.J.)

Lot Number

Quantity 100,000 capsules

Subpotent (80.0-86.0% of declared potency)

Michigan

6837

5,263 vials

Subpotent (25.0% of declared potency)

National

All lots

50,000 tablets

Drug efficacy study implementation

National

10104

200,000 capsules

Subpotent (86_8-87.8% of declared potency)

California Illinois Maryland Michigan New York

All lots

17,177 ,000 tablets in total lot

Fail USP content National uniformity requirements (79-146% potency range)

2058-03

625,000 tablets

Fails content uniformity requirements Fails content uniformity requirements (74.8-222.0% potency range) Subpotent (82.2-84.0% of declared potency) Subpotent (64.5-69.7% of declared potency) Chemical decom position (color changes and drop in pH) Adulterated with ephedrine

Wolins (Melville, N.Y.)

41733

2 , 434,000 tablets

Digoxin tablets USP 0.5 mg, 500's, 1,000's and 5,000's

Direct (Buffalo, N.Y.)

7575

183,000 tablets

Ergonovine maleate tablets USP 0.2 mg, 100's, 500's and 1,000' s Furacin topical solution (nitrofurazone NF 0.2%), 60 ml and 473 ml

Premo (S. Hackensack, N.J.)

C83596

144,300 tablets

Eaton (Norwich, N.Y.)

672758 672759

6 , 000 bottles

Dr. Madis (S. Hackensack, N.J.) Purepac (Elizabeth, N.J.) Schaeffer (West Nyack, N.Y.) Winsale (Brooklyn, N.Y.) Drugs Industries (DetrOit, Mich.)

All lots

Estimate of amount on market unavailable

All lots

55,000 tablets

Olbese No.2 tablets (amobarbital USP 60 mg, methamphetamine hydrochloride USP 10 mg, thyroid USP 150 mg), 500's and 1,000's

430

Product Distribution

10586

Digoxin tablets U SP 0.25 mg, 1,000's and 5,000's

Ipecac fluidextract, powdered root, syrup, whole root, all sizes

Recall Reason

Journal of the AMERICAN PHARMACEUTICAL ASSOCIATION

Drug efficacy study implementation

National

National

Oregon Pen n sylva n ia National

National

National International

Michigan

Product

t:irm Identified on ProduCt Lab~1

Lot Number

_ Quantity

Recali Reason

Product . Distribution

oxy·De 250 capsules (oxytetracycline hydroch loride NF 250 mg), all sizes

Davis-Edwards (New York, N.Y.)

All lots

4,000,000 capsules

Fails to produce satisfactory blood ievels

National

Phenazopyridine hydrochloride 50 mg w ith sulfisoxazole USP 500 tng t ablets , all sizes

Strong Cobb Arner (Cleveland, Ohio)

9831

175,000 tablets

Subpotent (782% of declared sulfisoxazole)

National

Pilo·S ophthalmic solution (pilocarp ine nitrate USP 2%),15 ml

Broemmel (San Francisco, Calif.)

4770

480 bottles

Subpotent (71-86% of declared potency)

Arizona California Hawaii Kansas · Louisiana Oregon Wash ington

Pilo·S ophthalmic solution ( pilocarpine nitrate USP 1/ 2%), 15 ml

BroemmeL (San Francisco, Calif.)

4765

400 bottles

Subpotent (55-66% of declared potency)

Arizona Hawaii California Kansas Louisiana Oregoh Washington

Pilo·S ophthalmic solution (pilocarpine nitrate USP 1%),15 ml

Broemmel (San Francisco, Calif.)

4768

1,780 bottles

Subpotent (65-73% of declared potency)

Arizona California Hawaii Kansas Louisiana Oregon Washington

Prednisone tablets USP 2.5 mg, 100's and 1,000's

Stayner (Berkeley, Calif.)

9MR182

48,400 tablets

Su perpotent (122.0% of declared potency)

Californ ia Massachusetts

Predisal tablets (prednisolone USP 0.75 mg, acet ylsalicylic acid USP 5 gr, sa licylamide 120 mg, dried aluminum hydroxide gel USP 100 mg), all sizes

Mallard (Detroit, Mich.)

All lots except X-27

350,000 tablets

Subpotent (40.2-85.7% of declared potency)

National

Propylthiouracil tablets USP 50 mg, all sizes

Rici,lyn (Philade.lphia , Pa.) Spencer Mead (Valley Stream, N.Y.)

All lots

No estimate of amount on market available

New labeling requirements

National

Re pository corticotropin injection USP 40 units/ml, 1 ml and 5 ml

Nationai (Philadelphia, Pa.)

6240L8 6241L8

16,752 1 rill viClls, 21,188 5 ml vials

Subpotent

National

Reserpine tablets USP 0.1 mg,l,OOO ' s

Belair. Surgical (Los Angeles, Calif.) Bellevue (Reading, Pa.) Daylin (lo~ Angeles, Calif.) Ladco (Los Angeles, Calif.) Medco (Muncie, lrid.)

12346

Estimate of tota Iqua ntity unavailable

Subpotent (50-59% of declared potency)

California Illinois Indiana Michigan New York Ohio Pennsylvania

Reserpine tablets USP 0.25 mg, 1,000's, 5,000's and 10,000's

Barrows Biochemical (Long Island, N.Y.)

10208

165,000 tablets

subpotent (88-91.6% of declared potency)

Massachusetts Ohio

SLi lfadiazine tablets USP 7.7 gr, all sizes

Richlyn (Philadelphia, Pa.) Rugby (Inwood ; N.Y.) Spencer Mead (Valley Stream, N.Y.)

All lots

No estimate of amount on market available

New labeling requ irements

National

Sulfa·Triple No.2 tablets (sulfamerazine USP 162 mg, sulfadiazine USP 162 mg, sulfamethazine USP 162 mg), all sizes

Richlyn (Ph iladelphia, Pa.) Rugby (Inwood, N.Y.) Spencer Mead (Valley Stream, N.Y.)

All lots

No estimate of quantity on market available

New labeling requirements

National

Su lfisoxazole tablets USP 0.5 gm , all sizes

Richlyn (Philadelphia, Pa.) Spencer Mead (Valley Stream, N.Y.)

All lots

No estimate of quantity on market available

New labeling requirements

National

Teles suspension (tellurium oxide 2.5%), 1 oz and 4 oz

Derm-Arts (Kansas City, Mo.)

3050

673 1 oz, 10740z

Chemical decom position (coior change and drop in pH)

Colorado Indiana Ohio Oregon

Trim Tabs No.1 tablets (amphetamine sUlfate NF 5 mg, thyroid USP 1 gr, atropine sulfate USP 1/360 gr, aloin 1/4 gr), a II sizes

Bellevue Surgical (Reading, Pa.) Richlyn (Philadelphia, Pa .)

14006 14012 14054

614,000 tablets

Drug efficacy study implementation

California New York Pennsylvania Wisconsin

TriR le Sulfa No.2 tablets (sulfamethazine USP 162 mg, sul f adiaz ine USP 162 mg, sulfamerazine USP 162 mg), all sizes

Davis-Edwards (Danbury, Conn.)

0209i9 020920 020930

150,000 tablets

Label mix-up (contains sulfathiazole instead of sulfamethazine)

New York

Vol. NS10, No.7, July 1970

431