Vancomycin Hydrochloride for Injection — Class I drug recall D-0638-2017
Terminated recall by Hospira Inc., A Pfizer Company, reported 2017-04-12, distributed nationwide. Presence of Particulate Matter: A hair was found stuck to the stopper of inside a single vial. The hair came i
| Recall number | D-0638-2017 |
|---|---|
| Product type | Drug |
| Classification | Class I |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Hospira Inc., A Pfizer Company, Lake Forest, IL, United States |
| Recall initiated | 2017-01-24 |
| Classified | 2017-04-05 |
| Reported by FDA | 2017-04-12 |
| Terminated | 2018-04-26 |
| Distributed | Nationwide (US) |
| Quantity | 30,880 vials |
| Reason classes | specification failure |
| NDC | 00409-6510-01 |
| Lot numbers | 591053A |
| Expiration dates | 2017-11-01 |
Product
Vancomycin Hydrochloride for Injection, USP, 10 grams, Pharmacy Bulk Package - Not For Direct Infusion, For Intravenous Use, packaged in 100 mL glass vial, Hospira, Inc., Lake Forest, IL 60045, NDC 0409-6510-01
Reason for recall
Presence of Particulate Matter: A hair was found stuck to the stopper of inside a single vial. The hair came in contact with the reconstituted drug product.
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-0638-2017. 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.