The Recall Desk
ModerateFDA (Drugs)·D-0759-2023·Announced 2023-05-31

Glimepiride 4 Milligram Tablets Nationwide Recalled for Manufacturing Practice Deviations

Amerisource Health Services LLC is recalling 129,849 bottles of Glimepiride Tablets, USP 4 mg nationwide due to manufacturing practice deviations identified during an FDA inspection. No illnesses have been reported.

What this means for you

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: FDA Class II recall for manufacturing practice deviations identified during inspection. No illnesses, injuries, or deaths have been reported. This is a precautionary recall for a potential quality issue.

Plain-English summary

Amerisource Health Services LLC is recalling Glimepiride Tablets, USP 4 mg across the United States. The recall affects 129,849 bottles distributed nationwide, packaged as 100-count and 500-count bottles. The tablets are manufactured by Intas Pharmaceuticals Limited in India for BluePoint Laboratories.

The recall was initiated following an FDA inspection that identified deviations from Current Good Manufacturing Practice (CGMP), which sets standards for pharmaceutical manufacturing. No illnesses or injuries related to this product have been reported.

Consumers taking this medication should consult their healthcare provider or pharmacist about their current supply and whether they need to switch to an alternative medication. Healthcare providers and pharmacists should discontinue dispensing affected lots and contact customers who may have received this product. Patients should not discontinue taking glimepiride without medical guidance, as this could affect their diabetes management.

The recalled product

Product
Glimepiride Tablets, USP, 4 mg, RX, Packaged as a) 100-count bottle, NDC# 68001-179-00; b) 500-count bottle, NDC# 68001-179-03, Manufactured by: Intas Pharmaceuticals Limited, Pharmez, Ahmedabad-382 213. INDIA. For BluePoint Laboratories
Manufacturer
Amerisource Health Services LLC
Category
Drug
Hazard
  • manufacturing-deviation

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (20)

  • Batches a) P2003403
  • EXP 05/31/2023
  • P2006593
  • EXP 11/30/2023
  • P2101152
  • EXP 01/31/2024
  • P2105014
  • EXP 06/30/2024
  • R2101440
  • EXP 09/30/2024
  • P2200774
  • EXP 01/31/2025
  • R2200664
  • EXP 04/30/2025 b) P2100705
  • P2104672
  • R2101435
  • R2200102
  • EXP 12/31/2024
  • R2200577
  • EXP 04/30/2025

Distribution

Distributed nationwide across the United States.

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