Drug Recalls

8

o

Drug 8 o Recalls

The following data have been compiled from the Federal Food and Drug Administration Weekly Recall Reports covering the period September 10, 1970, to October 7, 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 the 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

Lot Number

Quantity

Recall Reason

Product Distribution

Biotres ointment (in each lIs oz: zinc bacitracin 200 U, neomycin sulfate 3 mg, polymyxin B sulfate 4,000 U), lIs oz

Central (Seymour, Ind.)

WPZ

6,873 tubes

Subpotent (60.5% of declared polymyxin, 68.4% of declared neomycin)

Midwest

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

Aberdeen (Northvale, Mich.) Ulmer (Minneapolis, Minn.)

205IHJ5, 2058-06

1,005,000 tablets

Content uniformity (75.6-243.6% variance)

New York Ohio Pennsylvania Virginia

Digoxin tablets 0.25 mg, 100's, l,OOO's and 5,000's

Approved (Syracuse, N.Y.)

00437, 00447, 00787, 00867, 01107

244,000 tablets

Content uniformity (75.1-153.7% variance)

Massachusetts New York Ohio Pennsylvania

Digoxin tablets 0.25 mg, 1,000's

Sonnenberg (Philadelphia, Pa.)

59055

46,000 tablets

Content uniformity (variance not reported)

New Jersey Pennsylvania

D igoxin tablets 0.25 mg, 1,000's and 5,OOO's

United Research (Philadelphia, Pa.)

1785, 1785PJ, 1785QJ, 6944

858,000 tablets

Content uniformity (78.9-172.0% variance)

National

Drilitol nasal spray (methapyrilene

Smith Kline & French (Philadelphia, Pa.)

10E62, 20362, 59329, 69329

Not reported

NASINRC drug efficacy study implementation

National

Kalory capsules (thyroid 11/2 gr, amphetamine sulfate 71/2 gr, atropine sulfate 1/360 gr, phenobarbital l/S gr), 100's

Tyler (Gary, Ind.)

All lots

1,000 capsules

NAS/N RC drug efficacy study implementation

Illinois Indiana

Kalory-Plus capsules (thyroid 3 gr, amphetamine sulfate 15 mg, atrop in e su Ifate 1/180 gr, phenobarbital 1/4 gr), 100's

Tyler (Gary, Ind.)

All lots

1,000 capsules

NAS/N RC drug efficacy study implementation

Illinois Indiana

Methionine tablets 500 mg, 1,000's

Kirkman (Portland, Ore.)

M09914B

15,0000 tablets

Adulterated (aluminum particles)

Illinois Pennsylvania Washington

Pil-Digis tablets (powdered digitalis 100 mg), 100's and 1,000's

Davies Rose Hoyt (Needham, Mass.)

002C29

1,047,400 tablets

Superpotent (130.0% of declared potency)

National

Sodium salicylate enteric coated tablets USP 10 gr, l,OOO's

Parke-Davis (Detroit, Mich.)

KC-139

114,000 tablets

Fails USP disintegration test

National

Trisocort nasal spray (hydrocortisone 0.02%, paredrine 0.5%, phenylephrine hydrochloride 0.125%, gramacidin 0.005%, neomycin sulfate equivalent to neomycin base 0.6 mg/ml, polymyxin B sulfate equivalent to polymyxin B 2,000 U/ml, alcohol 1.1%, thimerosal 1: 100,000), 15 ml Spraypak

Smith Kline & French (Philadelphia, Pa.)

10V06, 20V06

Not reported

NASIN RC drug efficacy study implementation

National

hydrochloride 0.2%, gramacidin 0.0005%, polymyxin B sulfate equivalent to polymyxin B 500 U/ml, paredrine 1%, thimerosal 1: 100,000), 15 ml Spraypak

682

Journal of the AMERICAN PHARMACEUTICAL ASSOCIATION