Teva Recalls Subpotent Lansoprazole Delayed-Release Orally Disintegrating Tablets
Teva Pharmaceuticals USA is recalling 7,081 bottles of Lansoprazole 15 mg tablets because they contain less than the labeled amount of the active ingredient.
What this means for you
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: The FDA classified this recall as Class III, which by definition indicates that use of or exposure to the product is not likely to cause adverse health consequences.
Plain-English summary
Teva Pharmaceuticals USA is voluntarily recalling 7,081 bottles of Lansoprazole Delayed-Release Orally Disintegrating Tablets, 15 mg. The affected product is identified by Lot # 25Q002 and has an expiration date of 11/2019. The tablets are packaged in bottles containing 100 tablets (10 blister cards of 10 tablets each) and are available by prescription only.
The recall was initiated because the product is subpotent, meaning it contains less than the labeled amount of the active ingredient, lansoprazole. The FDA has classified this recall as Class III, which indicates that use of or exposure to the product is not likely to cause adverse health consequences.
The affected product was distributed nationwide in the United States. The recall was initiated on March 11, 2019, and was terminated on November 15, 2019. Patients who have this specific lot of medication should contact their healthcare provider or pharmacist for guidance on replacement or alternative treatment.
The recalled product
- Product
- LANSOPRAZOLE (LANSOPRAZOLE)
- Brand
- LANSOPRAZOLE
- Manufacturer
- Teva Pharmaceuticals USA
- Category
- Drug — Prescription Drug
- Hazard
- Affected units
- 7,081
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 (2)
- Lot #: 25Q002
- Exp. 11/2019
Distribution
Distributed nationwide across the United States.
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