Pfizer Recalls Daptomycin Injection Due to Microbial Contamination
Pfizer is recalling Daptomycin for Injection due to reports of adverse events indicative of infusion reactions related to microbiological contamination.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
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 recall is classified as FDA Class II and involves reports of adverse events indicative of infusion reactions related to microbiological contamination, which aligns with the rubric criteria for Severe severity (FDA Class II with hospitalization reports or significant injury reports).
Plain-English summary
Pfizer is recalling Daptomycin for Injection, 500 mg per vial, due to reports of adverse events indicative of infusion reactions related to microbiological contamination. The affected product is packaged as 1 Single-dose vial per carton and is available by prescription only.
The recall involves 234,680 vials distributed nationwide in the USA and Puerto Rico. Specific lot numbers and expiration dates are listed in the recall documentation, including lots 712453A, 771803A, 792103A, 800903A, 810853A, 841703A, 841753A, and 850553A.
Healthcare providers and patients should check their inventory and medication records for the specific lot numbers and expiration dates listed in the official recall notice. If you have questions about this recall, contact Pfizer or your healthcare provider.
The recalled product
- Product
- Daptomycin for Injection, 500 mg per vial, packaged as 1 Single-dose vial per carton, Rx only, Hospira, Inc., Lake Forest, IL 60045 USA, NDC 0409-0106-01.
- Manufacturer
- PFIZER
- Category
- Drug — Antibiotic Injection
- Affected units
- 234,680
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 (15)
- Lot #: 712453A
- Exp 1-Nov-18
- 771803A
- Exp 1-May-19
- 792103A
- Exp 1-Jul-19
- 800903A
- Exp 1-Aug-19
- 810853A
- Exp 1-Sep-19
- 841703A
- 841753A
- Exp 1-Dec-19
- 850553A
- Exp 1-Jan-20.
Distribution
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