Drug recall
ACYCLOVIR TABLETS, 400 mg, Rx only, 100 TABLETS, Distributed under the Par label. MANUFACTURED IN CANADA BY…
FDA recall event 28504 · Class II · Par Pharmaceutical
Key facts
| Event ID | 28504 |
|---|---|
| Recall numbers | D-154-4, D-155-4 |
| Recalling firm | Par Pharmaceutical |
| Product type | Drugs |
| Products | ACYCLOVIR TABLETS, 400 mg, Rx only, 100 TABLETS, Distributed under the Par label. MANUFACTURED IN CANADA BY: GENPHARM, INC. Toronto, Canada M8Z 2S6 For PAR PHARMACEUTICAL, INC. Spring Valley, NY 10977…, SOTATOL HCl TABLETS (sotalol hydrochloride),120 mg, 100 TABLETS, Rx only, Distributed under the Par label. MANUFACTURED IN CANADA BY: GENPHARM, INC. Toronto, Canada M8Z 2S6 For PAR PHARMACEUTICAL… |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Mislabeling: some bottles of "ACYCLOVIR TABLETS 400 mg" were affixed with an additional outer label (outsert) over the base label incorrectly identifying the product as "SOTALOL HCL TABLETS, 120 mg". |
| Initiation date | Mar 12, 2004 |
| City | Spring Valley |
| Country | United States |
| FEI number | 2434223 |
At a glance
- 1–9 Products in this recall
- 10–99 FDA inspections of this firm (FEI)
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA drug and product recalls
FDA enforcement reports list recalls of drugs, biologics, foods and other FDA-regulated products, classified by the potential health hazard.
Source: U.S. Food and Drug Administration (FDA), Enforcement Reports