Reported May 31, 2023 · Terminated
Glimepiride Tablets, USP, 4 mg, RX, Packaged as a) 100-count bottle, NDC# 68001-179-00; b) 500-count bottle, NDC#…
Amerisource Health Services LLC
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Amerisource Health Services LLC · 2550 John Glenn Ave Ste A · Columbus, OH · 43217-1188
Is this the product you have?
Glimepiride TabletsUSP4 mgRXPackaged as a) 100-count bottleNDC# 68001-179-00b) 500-count bottleNDC# 68001-179-03
- Manufactured byIntas Pharmaceuticals Limited, Pharmez, Ahmedabad-382 213. INDIA. For BluePoint Laboratories
- Lot codes and dates
18 of 18 products
Products covered by this recall # Product as published 1 Batches a) P2003403, EXP 05/31/2023 2 P2006593, EXP 11/30/2023 3 P2101152, EXP 01/31/2024 4 P2105014, EXP 06/30/2024 5 R2101440, EXP 09/30/2024 6 P2200774, EXP 01/31/2025 7 R2200664, EXP 04/30/2025 b) P2100705, EXP 01/31/2024 8 P2104672, EXP 06/30/2024 9 R2101435, EXP 09/30/2024 10 R2200102, EXP 12/31/2024 11 R2200577, EXP 04/30/2025 12 P2205870, EXP 08/31/2025 [500 count] Lot, expiry: P2100121, exp 11/30/2023 13 P2100705, exp 01/31/2024 14 P2104672, exp 06/30/2024 15 R2101435, exp 09/30/2024 16 R2200102, exp 12/31/2024 17 R2200577, exp R2200577 18 P2205870, exp 08/31/2025 - Amount recalled
- 129,849 bottles
This recall covers 3 products
The agency filed one notice per product. You are reading one of them; the other 2 are below.
Where it was sold
- Nationwide
Why it was recalled
CGMP Deviations: recalling drug products following an FDA inspection.
This product could cause temporary or reversible health problems — stop using it.
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