Metformin Hydrochloride Extended Release Tablets 1000 mg, 90-count bottle, Rx only, Manufactured by: Actavis Laboratories FL, Inc., Fort Lauderdale, FL, 33314, Distributed by: Actavis Pharma, Inc., Parsippany, NJ 07054 , NDC 00591-2412-19
Reported: October 31, 2018 Initiated: August 6, 2018 #D-0101-2019
Product Description
Metformin Hydrochloride Extended Release Tablets 1000 mg, 90-count bottle, Rx only, Manufactured by: Actavis Laboratories FL, Inc., Fort Lauderdale, FL, 33314, Distributed by: Actavis Pharma, Inc., Parsippany, NJ 07054 , NDC 00591-2412-19
Reason for Recall
Defective Delivery System: There is a potential for some tablets to be missing the laser drilling which might affect drug release.
Details
- Recalling Firm
- Teva Pharmaceuticals USA
- Units Affected
- N/A
- Distribution
- Product was distributed throughout the United States. Bulk product was distributed to Takeda, Deerfield, IL and may have been further distributed.
- Location
- North Wales, PA
Frequently Asked Questions
What product was recalled? ▼
Metformin Hydrochloride Extended Release Tablets 1000 mg, 90-count bottle, Rx only, Manufactured by: Actavis Laboratories FL, Inc., Fort Lauderdale, FL, 33314, Distributed by: Actavis Pharma, Inc., Parsippany, NJ 07054 , NDC 00591-2412-19. Recalled by Teva Pharmaceuticals USA. Units affected: N/A.
Why was this product recalled? ▼
Defective Delivery System: There is a potential for some tablets to be missing the laser drilling which might affect drug release.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on October 31, 2018. Severity: Moderate. Recall number: D-0101-2019.
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