The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-0099-2019·Announced 2018-10-31

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.

The agency’s classification

FDA (Drugs): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 4/5 (Severe).

The hazard poses a serious risk of illness, injury, or structural failure. 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
Hazard
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.

See all 7 products in this recall →

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