Daptomycin for Injection 500 mg per vial recall: CGMP Deviations
Daptomycin for Injection 500 mg per vial, Single-dose vial, Rx only, Manufactured by: Intas Pharmaceuticals Limited, Pharmez, Ahmedabad-382 213…
Why was Daptomycin for Injection 500 mg per vial recalled?
CGMP Deviations: recalling drug products following an FDA inspection.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
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;
- Product
- Daptomycin for Injection 500 mg per vial, Single-dose vial, Rx only, Manufactured by: Intas Pharmaceuticals Limited, Pharmez, Ahmedabad-382 213…
- Recalling firm
- Accord Healthcare, Inc.
- Quantity
- 228,760 vials
- Distribution
- United States including Puerto Rico and Canada
- Recall date
- March 8, 2023
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (drug)