Lupin Recalls Ceftriaxone Injection Vials Due to Particulate Matter
Lupin Pharmaceuticals is recalling Ceftriaxone for Injection USP, 500 mg, due to the presence of grey rubber particulate matter from stoppers.
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 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The agency classification is FDA Class I, which mandates a minimum severity score of 4 according to the rubric.
Plain-English summary
Lupin Pharmaceuticals, Inc. is recalling Ceftriaxone for Injection USP, 500 mg, packaged in single-use vials and boxes of ten vials. The recall affects specific lots of the product that were distributed nationwide in the USA and Puerto Rico.
The recall was initiated due to product complaints identifying grey flecks in reconstituted vials. These particles 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, 500 mg, and contact their supplier or Lupin Pharmaceuticals for further instructions.
The recalled product
- Product
- Ceftriaxone for Injection USP, 500 mg, packaged in a) one Single Use Vial (NDC 68180-622-01) and b) 10 Single Use Vials per box (NDC 68180-622-10); Rx only, Manufactured for: Lupin Pharmaceuticals, Inc., 111 South Calvert Street, Baltimore, Maryland 21202; Manufactured by…
- Manufacturer
- Lupin Pharmaceuticals Inc.
- Category
- Drug — Antibiotic
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 (14)
- Lot #: a) C600173
- Exp 08/19
- C600218
- Exp 09/19
- b) C600126
- C600127
- C600137
- C600143
- C600219
- C700146
- Exp 05/20
- C700208
- C700209
- Exp 09/20.
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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