Why it was recalled
Presence of Foreign Tablets/Capsules: Potential of Pravastatin tablet fragments in bottles of Valacyclovir 1 gm Tablets.
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
Lot numbers, UPCs & expiration codes
Lot W22042
Where it was sold
Nationwide
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-1061-2014
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Nov 8, 2013
- FDA report date
- Feb 12, 2014
- Quantity
- 7,020 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Teva Pharmaceuticals USA, Inc.
Original FDA data
Every field from FDA enforcement report D-1061-2014, exactly as published.
Show all FDA fields
- City
- Sellersville
- State
- PA
- Status
- Terminated
- Country
- United States
- Event ID
- 66872
- Address
- 650 Cathill Rd
- Code information
- Lot W22042
- Postal code
- 18960-1512
- Report date
- Feb 12, 2014
- Product type
- Drugs
- Recall number
- D-1061-2014
- Classification
- Class II
- Recalling firm
- Teva Pharmaceuticals USA, Inc.
- Product quantity
- 7,020 bottles
- Termination date
- Aug 27, 2014
- Reason for recall
- Presence of Foreign Tablets/Capsules: Potential of Pravastatin tablet fragments in bottles of Valacyclovir 1 gm Tablets.
- Voluntary / mandated
- Voluntary: Firm initiated
- 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
- Distribution pattern
- Nationwide
- Recall initiation date
- Nov 8, 2013
- Initial firm notification
- Letter
- Center classification date
- Feb 4, 2014