Agency classClass IOur severity:Severe FDA (Drugs)·D-0001-2015·Announced 2014-10-08

CUBICIN daptomycin injection vials recalled due to potential glass particulate matter

The FDA is recalling CUBICIN daptomycin injection vials because there may be glass particles present 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 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 classified this recall as Class I — 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. On that classification alone this is scored Severe; a score of Critical is reserved for recalls where a death or serious injury was reported. The agency gives the reason as: "Presence of Particulate Matter: Potential presence of glass particulate matter in the vials."

Plain-English summary

The FDA is recalling CUBICIN (daptomycin for injection), 500 mg single-use vials manufactured by Cubist Pharmaceuticals, Inc. The recall is based on the potential presence of glass particulate matter within the vials, which indicates a possible manufacturing quality issue that could affect product safety.

Consumers who have received these vials should follow the manufacturer's instructions for handling recalled products and consult their healthcare provider for guidance. Cubist Pharmaceuticals, Inc., the recalling firm, is responsible for addressing this recall and ensuring safe distribution.

The recalled product

Product: CUBICIN (daptomycin for injection), 500 mg single-use vial, Rx only, Manufactured for: Cubist Pharmaceuticals, Inc., Lexington, MA 02421, NDC 67919-011-01, UPC 3 67919-011-01 6.
Manufacturer: Cubist Pharmaceuticals, Inc.
Category: Drug — Injection
Hazard: glass-particulate
Affected units: 4,966,575

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 (20)

Lot #: 081753F
081803F
081853F
Exp 08/2014
090103F
090153F
090303F
090353F
090403F
090453F
090503F
Exp 09/2014
100503F
100553F
100603F
100653F
100703F
100753F
100803F
100853F

Distribution

Distributed nationwide across the United States.

Same manufacturer · Cubist Pharmaceuticals, Inc.

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