Cytarabine Injection 100 mg/5 mL — Class I drug recall D-1329-2015
Terminated recall by Mylan Institutional LLC, reported 2015-08-19, distributed nationwide. Presence of Particulate Matter
| Recall number | D-1329-2015 |
|---|---|
| Product type | Drug |
| Classification | Class I |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Mylan Institutional LLC, Rockford, IL, United States |
| Recall initiated | 2015-04-23 |
| Classified | 2015-08-13 |
| Reported by FDA | 2015-08-19 |
| Terminated | 2016-06-29 |
| Distributed | Nationwide (US) |
| Quantity | 8,340 vials |
| Reason classes | specification failure |
| NDC | 00069-0152-01, 00069-0152-02 |
| Lot numbers | 7801050 |
| Expiration dates | 2015-05 |
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.
Reason for recall
Presence of Particulate Matter
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-1329-2015. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.