Recalls / Class I
Class ID-1329-2015
Class I— FDA's most serious classification, issued when there is a reasonable probability that use of or exposure to the drug will cause serious adverse health consequences or death.
Product
Cytarabine Injection 100 mg/5 mL (20 mg/mL), 5 mL Single-Dose Vial (NDC 0069-0152-01), packaged in 10 x 5 mL Vials per carton (NDC 0069-0152-02), Rx only, Distributed by Pfizer Labs, Division of Pfizer Inc., New York, NY 10017.
- Affected lot / code info
- Lot # 7801050, Exp. Date. 05/2015
Why it was recalled
Presence of Particulate Matter
Recalling firm
- Firm
- Mylan Institutional LLC
- Notification channel
- Press Release
- Type
- Voluntary: Firm initiated
- Address
- 4901 Hiawatha Dr, N/A, Rockford, Illinois 61103-1287
Distribution
- Quantity
- 8,340 vials
- Distribution pattern
- Nationwide
Timeline
- Recall initiated
- 2015-04-23
- FDA classified
- 2015-08-13
- Posted by FDA
- 2015-08-19
- Terminated
- 2016-06-29
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-1329-2015. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.