Why it was recalled
Failed Stability Specifications: Micro Labs is recalling two lots due to out of specification results during stability testing.
Product description
GLIMEPIRIDE TABLETS, USP 2 mg, a)100 count bottle, (NDC 42571-101-01), b) 500 count Bottle (NDC 42571-101-05), Rx only, Manufactured by: Micro Labs Limited, Goa-403 722, INDIA, Manufactured for: Micro Labs USA, Inc., Princeton, NJ 08540
Lot numbers, UPCs & expiration codes
GLBG001 Exp.12/14, GLBG008 Exp. 06/15
Where it was sold
CT, FL, MD, MS, NY
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-0046-2015
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Oct 9, 2014
- FDA report date
- Nov 5, 2014
- Quantity
- 11,328 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Micro Labs Usa, Inc S
Original FDA data
Every field from FDA enforcement report D-0046-2015, exactly as published.
Show all FDA fields
- City
- Princeton
- State
- NJ
- Status
- Terminated
- Country
- United States
- Event ID
- 69133
- Address
- 104 Carnegie Ctr
- Address (line 2)
- Te 216
- Code information
- GLBG001 Exp.12/14, GLBG008 Exp. 06/15
- Postal code
- 08540-6232
- Report date
- Nov 5, 2014
- Product type
- Drugs
- Recall number
- D-0046-2015
- Classification
- Class II
- Recalling firm
- Micro Labs Usa, Inc S
- Product quantity
- 11,328 bottles
- Termination date
- Dec 29, 2015
- Reason for recall
- Failed Stability Specifications: Micro Labs is recalling two lots due to out of specification results during stability testing.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- GLIMEPIRIDE TABLETS, USP 2 mg, a)100 count bottle, (NDC 42571-101-01), b) 500 count Bottle (NDC 42571-101-05), Rx only, Manufactured by: Micro Labs Limited, Goa-403 722, INDIA, Manufactured for: Micro Labs USA, Inc., Princeton, NJ 08540
- Distribution pattern
- CT, FL, MD, MS, NY
- Recall initiation date
- Oct 9, 2014
- Initial firm notification
- Letter
- Center classification date
- Oct 27, 2014