Mylan Recalls Daptomycin Injection Due to Particulate Matter
Mylan Institutional LLC is recalling 18,480 vials of Daptomycin for Injection due to the presence of particulate matter. The product is distributed nationwide.
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 FDA classified this recall as Class I, which is the most serious classification indicating a reasonable probability that the product will cause serious adverse health consequences or death. This aligns with the rubric criterion for FDA Class I recalls requiring a score of at least 4.
Plain-English summary
Mylan Institutional LLC has initiated a voluntary recall of Daptomycin (Daptomycin) for Injection, 500 mg/vial, Single-Dose Vial. This prescription-only sterile product was manufactured for Mylan Institutional, LLC in Rockford, IL. The recall affects NDC 67457-813-50, specifically lot number 7605112 with an expiration date of October 2021. A total of 18,480 vials are involved in this recall.
The reason for the recall is the presence of particulate matter within the vials. Particulate matter refers to small particles that may be present in injectable solutions, which can pose health risks if administered to patients.
This product is distributed nationwide throughout the USA. Healthcare providers and consumers who possess this specific lot should stop using it immediately and contact Mylan Institutional LLC or their local distributor for return instructions.
The recalled product
- Product
- DAPTOMYCIN (DAPTOMYCIN)
- Brand
- DAPTOMYCIN
- Manufacturer
- Mylan Institutional LLC
- Category
- Drug — Injectable Antibiotic
- Affected units
- 18,480
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 (2)
- Lot #: 7605112
- Exp 10/2021
Distribution
Distributed nationwide across the United States.
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