U.S. marshals seize generic drugs

FDA Consumer, Nov, 1991

On behalf of FDA, U.S. marshals in four states last September seized certain generci prescription drugs made by Pharmaceutical Basics, Inc. (PBI), of Denver after PBI failed to recall 26 of its products. The agency requested the recalls because of uncertainties about data submitted before the drugs were approved and has notified the firm it will withdraw the approvals.

False statements, discrepancies, and omissions in records and information submitted to support applications for marketing approval raised doubts about whether PBI's products conferred the same therapeutic effects as other generic and brand-name versions of the drugs. PBI previously recalled its carbamazepine products because of similar concerns. (See "Epilepsy Drug Recalled" in the Updates section of the June 1991 FDA Consumer.)

FDA is unaware of any reports of problems from use of the drugs, which were sold under PBI's name and the names of numerous private and "store brand" labels. Since all the involved drugs are made by other firms, no shortages are expected. Consumers who have questions should talk to their physicians or pharmacists.

The products FDA asked PBI to recall are:

* acetohexamide--250-miligram (mg) and 500-mg tablets

* baclofen--10-mg and 20-mg tablets

* benztropine mesylate--0.5-mg, 1-mg, and 2-mg tablets

* chlordiazepoxide with amitriptyline hydrochloride--5-mg/12.5 mg and 10-mg/25-mg tables

* chlorpropamide--100-mg and 250-mg tablets

* clorazepate dipotassium--3.75-mg, &.5-mg, and 15-mg capsules

* desipramine hydrochloride--25-mg, 50-mg, 75-mg, and 100-mg tablets

* dipyridamole--25-mg, 50-mg, and 75-mg tablets

* flurazepam hydrochloride--15-mg and 30-mg capsules

* hydrocodone bitartrate with acetaminophen--5-mg/ 500-mg tablets

* hydroxyzine hydrochloride--10-mg, 25-mg, and 50-mg tablets

* lorazepam--1-mg and 2-mg tablets

* megestrol acetate--20-mg and 40-mg tablets

* methyclothiazide--5-mg tablets

* metoclopramide hydrochloride--10-mg tablets

* minoxidil--2.5-mg tablets

* oxybutynin chloride--5-mg tablets

* prazepam--5-mg and 10-mg capsules

* reserpine with hydroflumethiazide--0.125-mg/50-mg tablets

* sulfamethoxazole with trimethoprim--400-mg/80-mg and 800-mg/160-mg tablets

* temazepam--15-mg and 30-mg capsules

* timolol maleate--5,mg, 10-mg, and 20-mg tablets

* tolazamide--100-mg, 250-mg, and 500-mg tablets

* trazodone hydrochloride--50-mg and 100-mg tablets

* trimipramine maleate--25-mg, 50-mg, and 100-mg capsules

* warfarin sodium--2-mg, 2.5-mg, and 5-mg tablets