Teva Recalls Lansoprazole Triple Therapy Blister Packs Due to Impurities
Teva Pharmaceuticals is recalling 89,215 blister packs of triple therapy containing lansoprazole, clarithromycin, and amoxicillin due to failed impurity specifications.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, which typically involves a situation where use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences. The source text does not report any illnesses or injuries, and the hazard is a failure in impurity specifications rather than a high-risk pathogen or structural defect.
Plain-English summary
Teva Pharmaceuticals USA is recalling 89,215 blister packs of triple therapy, which contains lansoprazole delayed-release capsules, clarithromycin tablets, and amoxicillin capsules. The product is distributed nationwide.
The recall is being conducted because stability testing revealed that the lansoprazole component failed to meet impurity specifications. The affected products are identified by specific lot codes and expiration dates ranging from April 2014 to April 2015.
Consumers should stop using the recalled medication and contact their healthcare provider or pharmacist for guidance on alternative treatments. The recall is limited to the specific lot numbers and expiration dates listed in the official notice.
The recalled product
- Product
- 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, Amoxici
- Manufacturer
- Teva Pharmaceuticals USA
- Category
- Drug — Antibiotic / Acid Reflux
- Hazard
- Affected units
- 89,215
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (18)
- 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.
Distribution
Distributed nationwide across the United States.
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