Ceftriaxone Sodium recall: CGMP Deviations
Ceftriaxone Sodium (Sterile) USP active pharmaceutical ingredient, DMF No. 15931; Manufactured by: Lupin Limited, Unit-1, 198-202, New Industrial Area…
Why was Ceftriaxone Sodium recalled?
CGMP Deviations: active pharmaceutical ingredient intermediates failed specifications.
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?
Lot #: B4000935, Exp 01/17; B4005178, Exp 06/17; B4008730, B4008729, B4008727, B4008724, Exp 10/17; B5001647, B5001648, B5001649, Exp 02/18
- Product
- Ceftriaxone Sodium (Sterile) USP active pharmaceutical ingredient, DMF No. 15931; Manufactured by: Lupin Limited, Unit-1, 198-202, New Industrial Area…
- Recalling firm
- Lupin Pharmaceuticals Inc.
- Quantity
- 741.171 kg
- Distribution
- Nationwide and Puerto Rico
- Recall date
- June 8, 2016
- Classification
- Class III
- Status
- Terminated
- Agency
- FDA (drug)