Drug Recalls

Drug Recalls

0 The following data have been compiled from the Federal Food and Drug Administration Weekly Recall Reports covering the period April 15, 1971, to May 12, 1971 . 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

Amph etamine sulfate 15 mg, Penta atropine sulfate 1/I S!J gr, (San Francisco, Cal if.) phenobarbital15 mg, acetophenolisatin 0.5 mg, 1-thyroxin sodium 0.3 mg timed release capsules,

Lot Number

Quantity

Recall Reason

Product Distribution

All lots

1, 000 , 000 capsules

Marketed without approved NDA

California

Pausitrol brand by Don Hall (Portland , Ore.)

06976 11809

43,460 tablets

Chemical decomposition (free estrone)

California New Mexico Oregon Washin gton

Pausitrol brand by Don Hall (Portland , Ore.)

02090 08007

180,600 tablets

Chemical decomposition (free estrone)

California New Mexico Orego n Washington

Digitoxin tablets 0.1 mg, 1,000's and 5,000's

Altair (Perth Amboy, N.J.) S.F. Durst (Maryland Heig hts, Mo.) Generix Dru g Sales (Hollywood, Fla.) Hillco (Whittier, Calif.) Wasserot's (Kingston, Pa.)

0264-4

1,9;>2,000 tablets

Delayed disintegration

National

Digoxin tablets USP 0. 25 m g , 1,000' s

Altair (Perth Amboy, N.J.) Harvey (Philadelphia, Pa.) Hillco (Whittier, Ca lif.)

0246-3

900,000 tablets

Fails USP content uniformity test (72.2132.2% variance)

California Florida Massachusetts New York Pennsylvania

Flavoserp Bluline capsules (reserpine 0.25 mg, ascorbic acid 100 mg), 1,000's

Blue Line Chemical (St. Louis, Mo.)

All lots

25,000 tablets

NAS/ NRC drug efficacy study implementation

National

Neo-Cortef sterile suspension (in each ml: hydrocortisone acetate 50 mg, neomycin sulfate 5 mg), 1 ml and 5 ml

Upjohn (Kalamazoo, Mic h.)

All lots

26,297 of all package units

NAS/ NRC dru g efficacy study implementation

National

Nitroglycerine tablets USP 1/Iw gr, 100's and 1,000's

Stron g Cobb Arn er (Clevela nd, Ohio)

2526 with 2-letter suffix

242,600 tabl ets

Fails USP content uniformity test

National

Nitroglycerine tablets USP 'hoo gr, 100's 1,000's and 50,000's

Strong Cobb Arner (Cleveland, Ohio)

7555 with 2-letter suffix

279,500 tablets

National

Phenerga n injection (promethaz ine hydrochloride 25 m g and 50 m g jml), 1 m l ampules, 1 ml tubex and 10 ml vials Pentides-P 1200 aqueous solution (procaine penicillin G suspension USP 1,200,000 U/2.4 ml), 2.4 ml p rednisone tablets USP 2.5 mg, 100's and 1,000's

Wyeth (Marietta, Pa.)

All lots

1,275,000 of all packa ge units

Fails USP content uniformity test Particulate matter

Squibb (New York, N.Y.)

9M865

77,604 units

Non-sterile (bacterial contamination)

National

Stayner (Berkeley , Calif.)

OJR182 1AR182

Quantity not repo rted

Faulty disinte gra tion

California Montana

Pii-Digis pills (powdered digitalis USP 100 mg) , 1,000's and 5,000's Prednisone tablets USP 5.0 mg, 100's and 1, 000's

Davies Rose Hoyt (Needham, Mass.)

002A29

972,000 pills

National

Stayner (Berkeley, Ca lif.)

OJR051 1BR051

200,000 tablets

Superpotent (126.5% of declared potency) Fails USP dissolution test

package sizes not reported Conjugated water soluble estrogen t ab lets 0. 625 mg,

package sizes not repo rted Conjuga ted water soluble estro gen tablets l. 25 mg,

package sizes not reported

404

Journal of the AMERICAN PHARMACEUTICAL ASSOCIATION

National

Western U.S.

Product

Firm Identified on Product Label

Lot Number

Quantity

Recall Reason

Product Distribution

Quanti-Vite (F) pediatric drops (multiple vitamins with fluoride), 60 ml

Davies Rose Hoyt (Needham, Mass.)

All lots

1,800 bottles

Subpotent (vitamin C potency range from 48.9% upward)

National

Rinofeds capsules (ephedrine hydrochloride 1/s gr, atropine sulfate 1/4oo gr, pentobarbital 1/4 gr), 24's, 500's and 1,000's

Broemmel (San Francisco, Calif.)

5412

29,680 capsules

Ingredient mix-up (contains phenobarbital instead of pentobarbital)

Arizona California Oregon Washington

Sodium heparin injection 5,000 U/ml, 1 ml

Kapco (Kalamazoo, Mich.)

70312

9,675 vials

Particulate matter

National

Sodium heparin injection 1,000 U/ml, 1 ml, 10 ml and 30 ml

Kapco (Kalamazoo, Mich.)

15224,69352, 69493,69567, 70635

51,696 of all package units

Particulate matter

National

Sodium salicylate enteric coated tablets 10 gr, 100's and 1,000's

Don Hall (Portland, Ore.) Payless Drug Stores (Portland, Ore.) Sun Labs (Portland, Ore.)

0175, 12971, 12972-1, 12972-2

138,100 tablets

Fails USP disintegration test

California Idaho Oregon Washington

Vi-Spectrum pediatric drops (multiple vitamins), 60 ml

Davies Rose Hoyt (Needham, Mass.)

All lots

3,000 bottles

Subpotent (vitamin C potency range from 48.9% upward)

National

Continuing Education

University of North Carolina school of

pharmacy will sponsor a conference on ''Computer-Based Information Systems in the Practice of Pharmacy," July 18-21. Examined at the conference will be information requirements computer-based systems must meet in third-party payments, drug interactions and adverse reactions and drug recalls. Health care and pharmacy experts participating will include Vernon E. Wilson, health services and mental health administration, HEW; Keith M. Weikel, division of health evaluation, HEW, and David J. Jacobus, vice president, Merck Sharp & Dohme. To obtain further information, write to University of North Carolina School of Pharmacy, Chapel Hill, NC 27514. HEW, University of Cincinnati Medical Center and Educational Communications Foundation will sponsor a national conference on multimedia in the health sciences Julv 18-21 at the Sheraton Gibson Hotel in- Cincinnati. Major points of interest will be planning and managing the centralized educational resources center, identifying and solving common educational problems with the media, development, production and distribution of media-delivering and sharing its use and evaluating the use of media in the learning process. You may register at

Annual Leonard J. Dueker seminar participants at St. Louis College of Pharmacy April 7 visit with college administrators and staff. From left are Taylor E. LindM. Kenton horst, King, MD, William M. Landau, MD, Arnold P. Friedman, MD, and Charles C. Rabe.

the conference or write for advance registration-Educational Communications Foundation, 3150 Spring St., Fairfax, VA 22030. August 9-13 is slated for Western Insti-

tute of Drug Problems, the fourth annual summer school at Portland State University. The curriculum is designed for the health professions, law enforcement personnel, religious leaders, social workers, students and parents. General sessions will review fundamental aspects of

drug problems-historical, socio-cultural, medical and economic aspects. Inter~ disciplinary sessions stimulate exchange and exploration of information and techniques between interest groups. Career group sessions will provide individuals an opportunity to discuss the drug problem with others of the same special interest group. A two-day workshop on marijuana will precede the institute. To obtain registration forms, write to the Administrator, Fourth Annual Summer School, 603 Henry Building, Portland, OR 97204. Vol. NS11, No. 7, July 1971

405