Why it was recalled
Presence of Foreign Tablets/Capsules; report of Amlodipine Tablets found in 1000 count bottles of Metformin Hydrochloride Tablets USP
Product description
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
Lot numbers, UPCs & expiration codes
Lot 6121056, exp 5/2019
Where it was sold
AL, FL, GA, SC & TN
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0163-2017
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Nov 2, 2016
- FDA report date
- Dec 7, 2016
- Quantity
- 1739 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Ascend Laboratories LLC
Original FDA data
Every field from FDA enforcement report D-0163-2017, exactly as published.
Show all FDA fields
- City
- Montvale
- State
- NJ
- Status
- Terminated
- Country
- United States
- Event ID
- 75698
- Address
- 180 Summit Ave Ste 200
- Code information
- Lot 6121056, exp 5/2019
- Postal code
- 07645-1722
- Report date
- Dec 7, 2016
- Product type
- Drugs
- Recall number
- D-0163-2017
- Classification
- Class II
- Recalling firm
- Ascend Laboratories LLC
- Product quantity
- 1739 bottles
- Termination date
- Jun 7, 2017
- Reason for recall
- Presence of Foreign Tablets/Capsules; report of Amlodipine Tablets found in 1000 count bottles of Metformin Hydrochloride Tablets USP
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- 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
- Distribution pattern
- AL, FL, GA, SC & TN
- Recall initiation date
- Nov 2, 2016
- Initial firm notification
- Letter
- Center classification date
- Nov 29, 2016