Teva Recalls Metformin Hydrochloride Extended Release Tablets Due to Defective Delivery System
Teva Pharmaceuticals USA is recalling 3,397 bottles of Metformin Hydrochloride Extended Release Tablets, 500 mg, because some tablets may be missing laser drilling, which could affect 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 FDA classified this recall as Class II, which corresponds to a 'Severe' severity score (4) according to the rubric, as it involves a defect that could affect drug release.
Plain-English summary
Teva Pharmaceuticals USA is recalling 3,397 bottles of Metformin Hydrochloride Extended Release Tablets, 500 mg, 100-count bottles. The product is prescription-only and was manufactured by Actavis Laboratories, FL Inc. and distributed by Actavis Pharma, Inc. The specific lot number is 1210888A with an expiration date of 03/2019.
The recall was initiated due to a defective delivery system. There is a potential for some tablets to be missing the laser drilling, which might affect drug release. The FDA has classified this recall as Class II.
The product was distributed throughout the United States. Bulk product was also distributed to Takeda in Deerfield, IL, and may have been further distributed. Patients and healthcare providers should check their inventory for the specific lot number and expiration date listed above.
The recalled product
- Product
- Metformin Hydrochloride Extended Release Tablets, 500 mg, 100-count bottle, Rx only, Manufactured by: Actavis Laboratories, FL Inc., Fort Lauderdale, FL 33314, Distributed by: Actavis Pharma, Inc., Parsippany, NJ 07054, NDC 00591-2411-01
- Manufacturer
- Teva Pharmaceuticals USA
- Category
- Drug — Prescription Medication
- Affected units
- 3,397
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 #: 1210888A
- Exp 03/2019
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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