Lupin Recalls Ceftriaxone Injection Vials Due to Rubber Particulate Matter
Lupin Pharmaceuticals is recalling Ceftriaxone for Injection USP due to the presence of grey rubber particulate matter in the vials.
The agency’s classification
FDA (Drugs): Class I
Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 5/5 (Critical).
Highest-severity recall. The hazard can cause serious injury or death. Stop using the product now and follow the agency's instructions.
Our severity reasoning: The agency classification is FDA Class I, which mandates a severity score of 5 according to the rubric.
Plain-English summary
Lupin Pharmaceuticals, Inc. is recalling Ceftriaxone for Injection USP, 2 g, packaged in 10 Single Use Vials. The recall affects 3,792 boxes of the product, which is distributed nationwide in the USA and Puerto Rico. The specific lots involved are C600109 (Exp 05/19), C600129, and C600135 (Exp 08/19).
The recall was initiated because of product complaints identifying grey flecks in reconstituted vials. These flecks were identified as shredded rubber particulate matter originating from the stopper.
Healthcare providers and patients should stop using the affected lots of Ceftriaxone for Injection USP. The product is prescription-only, and users should contact their healthcare provider for guidance on alternative treatments or further instructions.
The recalled product
- Product
- Ceftriaxone for Injection USP, 2 g, packaged in 10 Single Use Vials (NDC 68180-644-01) per box, Rx only, Manufactured for: Lupin Pharmaceuticals, Inc., 111 South Calvert Street, Baltimore, Maryland 21202; Manufactured by: Lupin Limited, Mandideep 462 046 INDIA, NDC…
- Manufacturer
- Lupin Pharmaceuticals Inc.
- Category
- Drug — Antibiotic Injection
- Affected units
- 3,792
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 (5)
- Lot #: C600109
- Exp 05/19
- C600129
- C600135
- Exp 08/19
Distribution
Part of a larger recall action
This product is one of 4 recalled by Lupin Pharmaceuticals Inc. under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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