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Drug Recalls
Drug Recalls
The following data have been compiled from the Federal Food and Drug Adm·inistration We~kly B.ecaIl Reports covering the period December 9, 1971 , to January 19, 1972. Pharmacists and others possessing d rug 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 t he listed recalls which he feels will assist in completing the recall is u rged to send such data to the editor of this J OURNAL .
Product
Firm Identified on Product Label
Lot Number
Quantity
Recall Reason
Product Distribution
Alphadrol tablets (f luprednisolone NF 0.75 mg), 100's Arthralgen·PR tablet (salicylamide 250 mg, acetaminophen 250 mg, ascorbic acid 25 m g, prednisone 1 m g) , 100' s and 5, OOO ' s Coumadin tablets (sod ium warfarin 2.5 m g), 100' s in strip packagin g Coumadin tablets (sodium warfarin 5 mg), 100's in strip packagin g 1I0sone capsules (erythromycin estolate N F 250 m g), 100' s in strip packa g in g
Upjohn (Kalam azoo, M ich.)
1HX05
137,600 tablet s
Failed content uniformity test
Nati onal
Robins (Richmond , Va .)
All lots
600,000 tablets
NAs/N RC ·drug efficacy study implementation
National
Endo (Garden City, N.Y.)
CC 498B
2,195 cartons
National
Endo (Garden City, N.Y.)
CD 496B
8, 321 cartons
Lilly (Indian apolis , Ind.)
/los on e: 4VE66E Pack·a ge : 4SS06M
250 packa ges
Isoproterenol hydrochloride injection USP 0.2 mg/ml , 5 ml and 10 ml syrin g es
Br istol (Syracuse, N.Y.)
All lots
22,777 un its
Isoproterenol hydrochlor ide injection USP 0.02 m g /ml, 10 ml syringe
Bristol (Syracuse, N.Y.)
All lots
22,777 units
Metzog en t a blets (prednisolone 0.75 m g, ascorb ic acid 100 mg) , 100's Morphine sulfate for injection 8 m g , 10 m g and 15 m g , 2.5 ml with 1 ml d i luent in Va ri· ject v ials w ith 22 G or 25 G needles, l's Morphine sulfate for injection 8 m g, 10 mg and 15 m g , 2.5 ml with 1 ml d il uent, 5's and 25' s Plastic ballpoint pen-shaped container for carrying and dispen s ing n itroglycerin and other medication
Metz Pharmacal (Hillside, N.J.)
All lots
All on market
Label mix·up (some Packa ges contain 5 m g t ablets) Label mix·up (some packa ges contain 2.5 m g t ablets) Label mix·up (some strips labeled Darvon Compound 32 mg; cartons and ·cases labeled correctly) Subp otent (will not 'm aintain potency throu gh ex piration date) . Subpotent (will not m ai ntain potency throu gh exp iration . date) N a effective N DA
Ciba (Summit, N.J.)
All lots
42 , 650 u·n its of all strengths
Subp otent (68. 4%89.1 % of declared potency)
National
Ciba (Summit, N.J.)
All lots
429 ,175 un its of all stren gths
Subpotent (68.4%89.1% of decl ared potency)
National
Devolsey (St. Louis, Mo.) M. M. Robb ins (Shreveport , La .) C. E. Simmons (Lawton , Okla.) Robins (Richmond, Va .)
N/A
All manu factured
Not tight (loss of nitroglycerin potency: 50% in on e day to 90% in 30 days)
Arkansas Illinois India·na New Mexic o Oklahom a
71 836 7
61,488 bottles
100 m g /ml : 21301C9 250 m g/ml: 21401 £9, 21402B9, 21402CO 10326
100 mg/ml : 11,613 vials 250 mg/ml : 37 , 260 vials
Rob itet syrup (tetracycline hydroch loride 125 mg/ml), 15 ml Tetrachel injection (tetracycline hydrochloride 100 mg/ml and 250 m g/ml), 1 ml , 10's
Rachelle (Lon g Beach, Calif.)
Tetracycline syrup 125 m g/5 ml, 60 ml
American QuI nine (Plainview, N. Y.) Midway Medical (Glasgow, Ky.) Reine (Roosevelt, N.Y.) Rugby (Inwood, N.Y.) Henry Schein (Flush ing , N.Y.) Sherry (BaysMre, N.Y.) Spencer Mead (Valley Stream, N.Y.) Wolins (Melville, N.Y.)
29,328 bottles
National Na·tion al
National
National
New Jersey
Certification sample n ot representa t ive of batch; some bottles with no lot number or expiration date Subpotent
Virgin ia
Certification sample not repr esentative of batch
Kentucky New York
National
Vol. NS12, No. 3, March 1972
135
The following data have been compiled from the Federal Food and Drug Adm·inistration We~kly B.ecaIl Reports covering the period December 9, 1971 , to January 19, 1972. Pharmacists and others possessing d rug 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 t he listed recalls which he feels will assist in completing the recall is u rged to send such data to the editor of this J OURNAL .
Product
Firm Identified on Product Label
Lot Number
Quantity
Recall Reason
Product Distribution
Alphadrol tablets (f luprednisolone NF 0.75 mg), 100's Arthralgen·PR tablet (salicylamide 250 mg, acetaminophen 250 mg, ascorbic acid 25 m g, prednisone 1 m g) , 100' s and 5, OOO ' s Coumadin tablets (sod ium warfarin 2.5 m g), 100' s in strip packagin g Coumadin tablets (sodium warfarin 5 mg), 100's in strip packagin g 1I0sone capsules (erythromycin estolate N F 250 m g), 100' s in strip packa g in g
Upjohn (Kalam azoo, M ich.)
1HX05
137,600 tablet s
Failed content uniformity test
Nati onal
Robins (Richmond , Va .)
All lots
600,000 tablets
NAs/N RC ·drug efficacy study implementation
National
Endo (Garden City, N.Y.)
CC 498B
2,195 cartons
National
Endo (Garden City, N.Y.)
CD 496B
8, 321 cartons
Lilly (Indian apolis , Ind.)
/los on e: 4VE66E Pack·a ge : 4SS06M
250 packa ges
Isoproterenol hydrochloride injection USP 0.2 mg/ml , 5 ml and 10 ml syrin g es
Br istol (Syracuse, N.Y.)
All lots
22,777 un its
Isoproterenol hydrochlor ide injection USP 0.02 m g /ml, 10 ml syringe
Bristol (Syracuse, N.Y.)
All lots
22,777 units
Metzog en t a blets (prednisolone 0.75 m g, ascorb ic acid 100 mg) , 100's Morphine sulfate for injection 8 m g , 10 m g and 15 m g , 2.5 ml with 1 ml d i luent in Va ri· ject v ials w ith 22 G or 25 G needles, l's Morphine sulfate for injection 8 m g, 10 mg and 15 m g , 2.5 ml with 1 ml d il uent, 5's and 25' s Plastic ballpoint pen-shaped container for carrying and dispen s ing n itroglycerin and other medication
Metz Pharmacal (Hillside, N.J.)
All lots
All on market
Label mix·up (some Packa ges contain 5 m g t ablets) Label mix·up (some packa ges contain 2.5 m g t ablets) Label mix·up (some strips labeled Darvon Compound 32 mg; cartons and ·cases labeled correctly) Subp otent (will not 'm aintain potency throu gh ex piration date) . Subpotent (will not m ai ntain potency throu gh exp iration . date) N a effective N DA
Ciba (Summit, N.J.)
All lots
42 , 650 u·n its of all strengths
Subp otent (68. 4%89.1 % of declared potency)
National
Ciba (Summit, N.J.)
All lots
429 ,175 un its of all stren gths
Subpotent (68.4%89.1% of decl ared potency)
National
Devolsey (St. Louis, Mo.) M. M. Robb ins (Shreveport , La .) C. E. Simmons (Lawton , Okla.) Robins (Richmond, Va .)
N/A
All manu factured
Not tight (loss of nitroglycerin potency: 50% in on e day to 90% in 30 days)
Arkansas Illinois India·na New Mexic o Oklahom a
71 836 7
61,488 bottles
100 m g /ml : 21301C9 250 m g/ml: 21401 £9, 21402B9, 21402CO 10326
100 mg/ml : 11,613 vials 250 mg/ml : 37 , 260 vials
Rob itet syrup (tetracycline hydroch loride 125 mg/ml), 15 ml Tetrachel injection (tetracycline hydrochloride 100 mg/ml and 250 m g/ml), 1 ml , 10's
Rachelle (Lon g Beach, Calif.)
Tetracycline syrup 125 m g/5 ml, 60 ml
American QuI nine (Plainview, N. Y.) Midway Medical (Glasgow, Ky.) Reine (Roosevelt, N.Y.) Rugby (Inwood, N.Y.) Henry Schein (Flush ing , N.Y.) Sherry (BaysMre, N.Y.) Spencer Mead (Valley Stream, N.Y.) Wolins (Melville, N.Y.)
29,328 bottles
National Na·tion al
National
National
New Jersey
Certification sample n ot representa t ive of batch; some bottles with no lot number or expiration date Subpotent
Virgin ia
Certification sample not repr esentative of batch
Kentucky New York
National
Vol. NS12, No. 3, March 1972
135