Why it was recalled
Failed Tablet/Capsule Specifications: There is a potential for broken tablets.
Product description
Niacin Extended Release Tablets, USP, 500 mg, 90 count bottle, Rx Only, Teva Pharmaceuticals USA, Inc., Sellersville, PA, 18960, NDC 0093-7392-98
Lot numbers, UPCs & expiration codes
Lot#: 32900349B, Exp: 12/2014
Where it was sold
Nationwide and Puerto Rico, American Samoa, Virgin Islands, and Canal Zone
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-396-2014
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Nov 26, 2013
- FDA report date
- Jan 8, 2014
- Quantity
- 10,512 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Teva Pharmaceuticals USA
Original FDA data
Every field from FDA enforcement report D-396-2014, exactly as published.
Show all FDA fields
- City
- Horsham
- State
- PA
- Status
- Terminated
- Country
- United States
- Event ID
- 66955
- Address
- 425 Privet Rd
- Code information
- Lot#: 32900349B, Exp: 12/2014
- Postal code
- 19044-1220
- Report date
- Jan 8, 2014
- Product type
- Drugs
- Recall number
- D-396-2014
- Classification
- Class II
- Recalling firm
- Teva Pharmaceuticals USA
- Product quantity
- 10,512 bottles
- Termination date
- Aug 27, 2014
- Reason for recall
- Failed Tablet/Capsule Specifications: There is a potential for broken tablets.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Niacin Extended Release Tablets, USP, 500 mg, 90 count bottle, Rx Only, Teva Pharmaceuticals USA, Inc., Sellersville, PA, 18960, NDC 0093-7392-98
- Distribution pattern
- Nationwide and Puerto Rico, American Samoa, Virgin Islands, and Canal Zone
- Recall initiation date
- Nov 26, 2013
- Initial firm notification
- Letter
- Center classification date
- Jan 2, 2014