Teva Recalls Fortamet Extended-Release Tablets Due to Defective Delivery System
Teva Pharmaceuticals USA is recalling specific lots of Fortamet (metformin HCl) extended-release tablets because some may lack laser drilling, potentially affecting drug release.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The agency classification is FDA Class II. Per the rubric, FDA Class II recalls are assigned a score of 4 (Severe), particularly when the defect involves a potential failure in drug delivery which could lead to adverse health consequences.
Plain-English summary
Teva Pharmaceuticals USA is voluntarily recalling 13,225 bottles of Fortamet (metformin HCl) extended-release tablets, 1000 mg, 60-count bottles. The recall involves specific lots (1237868A and 1248900A) with an expiration date of May 2020. The product was distributed throughout the United States, with bulk product also distributed to Takeda in Deerfield, IL, which may have led to further distribution.
The recall is due to a defective delivery system. There is a potential for some tablets to be missing the laser drilling, which might affect the release of the drug. This is an FDA Class II recall, indicating a situation where use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences.
Patients and healthcare providers should check their inventory for the affected NDC (59630-575-60) and lot numbers. If the product is found, it should be quarantined and not dispensed or used. Consumers should contact their healthcare provider for guidance on alternative treatment options if they have been prescribed this specific medication.
The recalled product
- Product
- Fortamet (metformin HCl) extended release tablets, 1000 mg, 60-count bottle, Rx only, Manufactured by: Actavis Laboratories FL, Inc., Fort Lauderdale, FL 33314, Distributed by: Shionogi Inc., Florham Park, NJ 07932, NDC 59630-575-60
- Manufacturer
- Teva Pharmaceuticals USA
- Category
- Drug — Prescription Medication
- Affected units
- 13,225
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 (3)
- Lot #: 1237868A
- 1248900A
- Exp 5/2020
Distribution
Distribution scope not specified by the agency.
Part of a larger recall action
This product is one of 7 recalled by Teva Pharmaceuticals USA under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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