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.
FDA recall notice · announced December 4, 2013 · Apotex
Class II FDA/FSIS Class II: use may cause temporary or medically reversible adverse health consequences.
The product
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.
Reason for recall
Presence of Particulate Matter: Product from lot KF2199, may contain tablets with pieces of nitrile rubber glove embedded within the tablets.
Notes
Distribution: Nationwide and Puerto Rico
Lot/code information: Lot # KF2199 Exp 07/15
Quantity: 4,844 bottles
Status: Terminated
Products in this recall event:
- 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. (D-017-2014)
Source: U.S. Food and Drug Administration public recall data. This page reports official records and is not legal, medical, or repair advice.