Why it was recalled
CGMP Deviations: recalling drug products following an FDA inspection.
Product description
Glimepiride Tablets, USP, 1 mg, RX, Packaged as a)100-count bottle, NDC# 68001-177-00; b) 500-count bottle, NDC# 68001-177-03; Manufactured by: Intas Pharmaceuticals Limited, Pharmez, Ahmedabad-382 213. INDIA. For BluePoint Laboratories
Lot numbers, UPCs & expiration codes
Batches a) P2002616, EXP 04/30/2023; P2006509, EXP 11/30/2023; P2103572, EXP 04/30/2024; P2106811, EXP 09/30/2024; R2200578, EXP 04/30/2025 b)P2100095, EXP 11/30/2023; P2100624, EXP 01/31/2024; P2101780, EXP 02/29/2024; P2107383, EXP 09/30/2024; P2201505, EXP 02/28/2025; R2201109, EXP 06/30/2025
Where it was sold
Nationwide USA
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-0757-2023
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Mar 17, 2023
- FDA report date
- May 31, 2023
- Quantity
- 63,335 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Amerisource Health Services LLC
Original FDA data
Every field from FDA enforcement report D-0757-2023, exactly as published.
Show all FDA fields
- City
- Columbus
- State
- OH
- Status
- Terminated
- Country
- United States
- Event ID
- 92058
- Address
- 2550 John Glenn Ave Ste A
- Code information
- Batches a) P2002616, EXP 04/30/2023; P2006509, EXP 11/30/2023; P2103572, EXP 04/30/2024; P2106811, EXP 09/30/2024; R2200578, EXP 04/30/2025 b)P2100095, EXP 11/30/2023; P2100624, EXP 01/31/2024; P2101780, EXP 02/29/2024; P2107383, EXP 09/30/2024; P2201505, EXP 02/28/2025; R2201109, EXP 06/30/2025
- Postal code
- 43217-1188
- Report date
- May 31, 2023
- Product type
- Drugs
- Recall number
- D-0757-2023
- Classification
- Class II
- Recalling firm
- Amerisource Health Services LLC
- Product quantity
- 63,335 bottles
- Termination date
- Sep 6, 2024
- Reason for recall
- CGMP Deviations: recalling drug products following an FDA inspection.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Glimepiride Tablets, USP, 1 mg, RX, Packaged as a)100-count bottle, NDC# 68001-177-00; b) 500-count bottle, NDC# 68001-177-03; Manufactured by: Intas Pharmaceuticals Limited, Pharmez, Ahmedabad-382 213. INDIA. For BluePoint Laboratories
- Distribution pattern
- Nationwide USA
- Recall initiation date
- Mar 17, 2023
- Initial firm notification
- Letter
- Center classification date
- May 19, 2023