D-1329-2015 Class I Terminated
FDA drug recall D-1329-2015 was initiated by Mylan Institutional LLC on Apr 23, 2015 and is designated Class I. Reason for recall: Presence of Particulate Matter The recall status is terminated (terminated Jun 29, 2016). Affected quantity: 8,340 vials.
Recall Details
- Product Type
- Drugs
- Report Date
- Aug 19, 2015
- Initiation Date
- Apr 23, 2015
- Termination Date
- Jun 29, 2016
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 8,340 vials
Product Description
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.
Reason for Recall
Presence of Particulate Matter
Distribution Pattern
Nationwide
Code Information
Lot # 7801050, Exp. Date. 05/2015
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-1329-2015
- openFDA file date
- Nov 3, 2026
- Loaded by RegDataLab
- Nov 4, 2026