Drug recall
Acyclovir Tablets USP 800 mg,(NDC 60505-5307-1), Rx only, Manufactured by Apotex Inc., Toronto, Ontario…
FDA recall event 66807 · Class II · Apotex Inc.
Key facts
| Event ID | 66807 |
|---|---|
| Recall numbers | D-017-2014 |
| Recalling firm | Apotex Inc. |
| Product type | Drugs |
| Products | Acyclovir Tablets USP 800 mg ,(NDC 60505-5307-1), Rx only, Manufactured by Apotex Inc., Toronto, Ontario, Canada M9L 1T9, Manufactured for Apotex Corp.,Weston, Florida 33326. |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Presence of Particulate Matter: Product from lot KF2199, may contain tablets with pieces of nitrile rubber glove embedded within the tablets. |
| Initiation date | Jul 17, 2013 |
| Report date | Dec 4, 2013 |
| Termination date | Aug 4, 2014 |
| City | Toronto |
| Country | Canada |
| FEI number | 3002906944 |
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 · Source date: