Drug 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.
D-017-2014
Product summary
- Firm
- Apotex Inc.
- Event
- Event 66807
- Status
- Terminated
- Classification
- Class II
- Quantity
- 4,844 bottles
- Official record key
drug-enforcement:D-017-2014
Official wording
Reason: Presence of Particulate Matter: Product from lot KF2199, may contain tablets with pieces of nitrile rubber glove embedded within the tablets.
Code information: Lot # KF2199 Exp 07/15
Distribution pattern: Nationwide and Puerto Rico
Derived failure modes
-
Foreign material or chemical contamination
Particulate Matter