Glimepiride Tablets, USP, 2 mg, RX, Packaged as a ) 100-count bottle, NDC# 68001-178-00; b) 500-count bottle; NDC# 68001-178-03 Manufactured by: Intas Pharmaceuticals Limited, Pharmez, Ahmedabad-382 213, INDIA. For BluePoint Laboratories
Reported: May 31, 2023 Initiated: March 17, 2023 #D-0758-2023
Product Description
Glimepiride Tablets, USP, 2 mg, RX, Packaged as a ) 100-count bottle, NDC# 68001-178-00; b) 500-count bottle; NDC# 68001-178-03 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
- 105,361 bottles
- Distribution
- Nationwide USA
- Location
- Columbus, OH
Frequently Asked Questions
What product was recalled? ▼
Glimepiride Tablets, USP, 2 mg, RX, Packaged as a ) 100-count bottle, NDC# 68001-178-00; b) 500-count bottle; NDC# 68001-178-03 Manufactured by: Intas Pharmaceuticals Limited, Pharmez, Ahmedabad-382 213, INDIA. For BluePoint Laboratories. Recalled by Amerisource Health Services LLC. Units affected: 105,361 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-0758-2023.
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