The Recall Desk
ModerateFDA (Drugs)·D-0382-2023·Announced 2023-03-08

Daptomycin Injectable Recalled Due to Manufacturing Deviations

Accord Healthcare is recalling Daptomycin for Injection due to manufacturing practice deviations discovered during FDA inspection. No illnesses or injuries 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 with no reported illnesses or injuries. The hazard is based on manufacturing compliance deviations rather than a documented safety event, making this a precautionary recall without evidence of actual harm.

Plain-English summary

Accord Healthcare, Inc. is recalling Daptomycin for Injection, 500 mg per vial, due to Current Good Manufacturing Practice (CGMP) deviations discovered during an FDA inspection. The product (NDC 16729-435-05) is manufactured by Intas Pharmaceuticals Limited in Ahmedabad, India, and distributed by Accord Healthcare. This is a Class II recall affecting approximately 228,760 vials.

The recalled product was distributed throughout the United States, including Puerto Rico and Canada. Multiple production batches are involved, with expiration dates ranging from September 2023 through July 2025. The affected batch numbers are R2101282, R2101600, R2200002, R2200028, R2200116, R2200142, R2200152, R2200165, R2200190, and R2201042.

CGMP deviations indicate potential quality control or manufacturing process issues that could affect product safety or effectiveness. However, no illnesses or injuries related to this product have been reported to the FDA.

Patients currently taking Daptomycin should not discontinue treatment without consulting their healthcare provider. Healthcare facilities should quarantine affected vials and contact their pharmaceutical supplier for replacement product or further instructions.

The recalled product

Product
DAPTOMYCIN (DAPTOMYCIN)
Brand
DAPTOMYCIN
Manufacturer
Accord Healthcare, Inc.
Category
Drug
Hazard
  • cgmp-deviation
  • manufacturing-defect

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 (15)

  • Batches: R2101282
  • Exp. Date 9/30/2023
  • R2101600
  • Exp. Date 11/30/2024
  • R2200002
  • R2200028
  • R2200116
  • R2200142
  • R2200152
  • Exp. Date 12/31/2024
  • R2200165
  • R2200190
  • Exp. Date 1/31/2025
  • R2201042
  • Exp. Date 7/31/2025

UPCs (2)

  • 0316729435055
  • 316729435055

Distribution

Distribution scope not specified by the agency.

Related recalls

Same brand · DAPTOMYCIN

Same category