Drug product
Valacyclovir Hydrochloride Tablets, 1 g, 30 count bottle, Rx only manufactured in Israel by Teva Pharmaceuticals Ind., LTD, Jerusalem, Israel, Manufactured for Teva Pharmaceuticals USA, Sellersville, PA. NDC #0093-7259-56
D-1061-2014
Product summary
- Event
- Event 66872
- Status
- Terminated
- Classification
- Class II
- Quantity
- 7,020 bottles
- Official record key
drug-enforcement:D-1061-2014
Official wording
Reason: Presence of Foreign Tablets/Capsules: Potential of Pravastatin tablet fragments in bottles of Valacyclovir 1 gm Tablets.
Code information: Lot W22042
Distribution pattern: Nationwide
Derived failure modes
-
Foreign material or chemical contamination
Foreign Tablets