Why it was recalled
Failed Impurities/Degradation Specifications: This recall is due to out of specification for impurities test results obtained during stability testing for Lansoprazole.
Product description
triple therapy, LANSOPRAZOLE DR Capsules USP 30mg, CLARITHROMYCIN Tablets USP 500mg, AMOXICILLIN Capsules USP 500mg, 8 count Blister Pack Lansoprazole DR Capsules USP & Clarithromycin Tablets USP, MANUFACTURED Israel for Teva Pharmaceuticals USA, Sellersville, PA 18960, Amoxicillin Capsules USP manufactured in Canada, for Teva Pharmaceuticals USA, Sellersville, PA 18960. NDC# 0093-8055-78
Lot numbers, UPCs & expiration codes
35427772A, 35427773A, 35427774A, 35427916A, 35428048A, 35428051A, Exp. 04/14; 35428127A, 35428218A, Exp. 07/14; 35429573A, 35429574A, 35429575A, Exp. 02/15; 35429697A, Exp. 03/15; 35430184A, Exp. 04/15.
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-1499-2014
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Apr 1, 2014
- FDA report date
- Aug 6, 2014
- Quantity
- 89,215 blister pack
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Teva Pharmaceuticals USA
Original FDA data
Every field from FDA enforcement report D-1499-2014, exactly as published.
Show all FDA fields
- City
- Horsham
- State
- PA
- Status
- Terminated
- Country
- United States
- Event ID
- 67882
- Address
- 425 Privet Rd
- Code information
- 35427772A, 35427773A, 35427774A, 35427916A, 35428048A, 35428051A, Exp. 04/14; 35428127A, 35428218A, Exp. 07/14; 35429573A, 35429574A, 35429575A, Exp. 02/15; 35429697A, Exp. 03/15; 35430184A, Exp. 04/15.
- Postal code
- 19044-1220
- Report date
- Aug 6, 2014
- Product type
- Drugs
- Recall number
- D-1499-2014
- Classification
- Class II
- Recalling firm
- Teva Pharmaceuticals USA
- Product quantity
- 89,215 blister pack
- Termination date
- Nov 20, 2014
- Reason for recall
- Failed Impurities/Degradation Specifications: This recall is due to out of specification for impurities test results obtained during stability testing for Lansoprazole.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- triple therapy, LANSOPRAZOLE DR Capsules USP 30mg, CLARITHROMYCIN Tablets USP 500mg, AMOXICILLIN Capsules USP 500mg, 8 count Blister Pack Lansoprazole DR Capsules USP & Clarithromycin Tablets USP, MANUFACTURED Israel for Teva Pharmaceuticals USA, Sellersville, PA 18960, Amoxicillin Capsules USP manufactured in Canada, for Teva Pharmaceuticals USA, Sellersville, PA 18960. NDC# 0093-8055-78
- Distribution pattern
- Nationwide
- Recall initiation date
- Apr 1, 2014
- Initial firm notification
- Letter
- Center classification date
- Jul 31, 2014