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.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a risk-of-harm product (injection medication) where no injuries or deaths have been reported, aligning with the rubric's definition for High severity (risk-of-harm products where injury has not yet been reported).
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
- 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.
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