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

Class I - Dangerous

What Should You Do?

  1. Check if you have this product:
    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
  2. Do not eat it: Even if it looks and smells fine, do not consume this product.
  3. Throw it away or return it: You can return the product to the store for a full refund.
  4. Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
  5. Report problems: Report any issues to the FDA's Safety Reporting Portal.

⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.

Recall Details

Company:
Amerisource Health Services LLC
Reason for Recall:
CGMP Deviations: recalling drug products following an FDA inspection.
Classification:
Class I - Dangerous

Dangerous or defective products that predictably could cause serious health problems or death.

Status:
terminated

Product Information

Full 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

Product Codes/Lot Numbers:

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

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: D-0757-2023

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