Valacyclovir Hydrochloride Tablets, 1 g, 30 count bottle, Rx only manufactured in Israel by Teva ...
FDA Recall #D-1061-2014 — Class II — November 8, 2013
Product Description
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
Reason for Recall
Presence of Foreign Tablets/Capsules: Potential of Pravastatin tablet fragments in bottles of Valacyclovir 1 gm Tablets.
Recalling Firm
Teva Pharmaceuticals USA, Inc. — Sellersville, PA
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Drugs
Product Quantity
7,020 bottles
Distribution
Nationwide
Code Information
Lot W22042
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated