Recalls / Class II
Class IID-0163-2017
Product
Metformin Hydrochloride Tablets, USP 500 mg, 1000 tablets, Rx Only Manufactured by: Alkem Laboratories Ltd., Mumbai - 400 013, India, Distributed by: Ascend Laboratories, LLC, Montvale, NJ NDC 67877-217-10
- Brand name
- Metformin Hydrochloride
- Generic name
- Metformin Hydrochloride
- Active ingredient
- Metformin Hydrochloride
- Route
- Oral
- NDCs
- 67877-217, 67877-218, 67877-221, 67877-413, 67877-414
- FDA application
- ANDA091184
- Affected lot / code info
- Lot 6121056, exp 5/2019
Why it was recalled
Presence of Foreign Tablets/Capsules; report of Amlodipine Tablets found in 1000 count bottles of Metformin Hydrochloride Tablets USP
Recalling firm
- Firm
- Ascend Laboratories LLC
- Manufacturer
- Ascend Laboratories, LLC
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 180 Summit Ave Ste 200, Montvale, New Jersey 07645-1722
Distribution
- Quantity
- 1739 bottles
- Distribution pattern
- AL, FL, GA, SC & TN
Timeline
- Recall initiated
- 2016-11-02
- FDA classified
- 2016-11-29
- Posted by FDA
- 2016-12-07
- Terminated
- 2017-06-07
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0163-2017. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.