Recalls / Class II
Class IID-1061-2014
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
- Affected lot / code info
- Lot W22042
Why it was recalled
Presence of Foreign Tablets/Capsules: Potential of Pravastatin tablet fragments in bottles of Valacyclovir 1 gm Tablets.
Recalling firm
- Firm
- Teva Pharmaceuticals USA, Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 650 Cathill Rd, Sellersville, Pennsylvania 18960-1512
Distribution
- Quantity
- 7,020 bottles
- Distribution pattern
- Nationwide
Timeline
- Recall initiated
- 2013-11-08
- FDA classified
- 2014-02-04
- Posted by FDA
- 2014-02-12
- Terminated
- 2014-08-27
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-1061-2014. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.