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
Reported: May 31, 2023 Initiated: March 17, 2023 #D-0757-2023
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
Reason for Recall
CGMP Deviations: recalling drug products following an FDA inspection.
Details
- Recalling Firm
- Amerisource Health Services LLC
- Units Affected
- 63,335 bottles
- Distribution
- Nationwide USA
- Location
- Columbus, OH
Frequently Asked Questions
What product was recalled? ▼
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. Recalled by Amerisource Health Services LLC. Units affected: 63,335 bottles.
Why was this product recalled? ▼
CGMP Deviations: recalling drug products following an FDA inspection.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on May 31, 2023. Severity: Moderate. Recall number: D-0757-2023.
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