FDA Drug recall D-0638-2017
Vancomycin Hydrochloride for Injection, USP, 10 grams, Pharmacy Bulk Package - Not For Direct Infusion, For Intravenous Use, packaged in 10…
- FDA Drug
- Class I
- terminated
- Published 2017-04-12
On 2017-04-12 the FDA classified a Class I recall of Vancomycin Hydrochloride for Injection, USP, 10 grams, Pharmacy Bulk Package - Not For Direct Infusion, For Intravenous Use, packaged in 10… by Hospira A Pfizer, citing 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.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0638-2017 |
| Classification | Class I |
| Status | terminated |
| Initiated | 2017-01-24 |
| Published | 2017-04-12 |
| Last updated | 2026-09-13 11:51 UTC |
| Company | Hospira A Pfizer |
| Distribution | US |
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
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.
Identifiers
| code_info | Lot # 591053A, Exp 11/1/2017 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:51 UTC. Current status: terminated.
Other recalls by Hospira A Pfizer
- Labetalol Hydrochloride Injection, USP, 100 mg/ 20 mL (5 mg/mL), 20 mL Multidose Vial, Rx only, labeled as a) Hospira, Inc., Lake Forest, I…
FDA Drug · Class II · 2018-03-14 · Hospira A Pfizer - Neut Sodium Bicarbonate 4% (2.4 mEq) Additive Solution 5 mL , a.) Single-dose vial (NDC 0409-6609-02), b.) 25 vial carton (NDC 0409-6609-25…
FDA Drug · Class II · 2017-08-09 · Hospira A Pfizer - Potassium Phosphates Inj., USP, 45 mM (3 mM P/mL) Also contains: 66 mEq K+ (4.4 mEq/mL) 15 mL, Single-dose, Caution: Must Be Diluted, Rx On…
FDA Drug · Class II · 2017-08-09 · Hospira A Pfizer - 8.4% Sodium Bicarbonate Inj., USP 50 mL Single-dose, 50 mEq (1 mEq/mL) 4.2 grams (84 mg/mL), Rx Only, Mfd by Hospira, INC, Lake Forest, IL…
FDA Drug · Class II · 2017-08-09 · Hospira A Pfizer - Succinylcholine Chloride Injection, USP 200 mg (20 mg/mL) Quelicin Multiple-dose vial, 10 mL, For I.V. or I.M. use. a.) one vial (NDC: 0409…
FDA Drug · Class II · 2017-08-09 · Hospira A Pfizer
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0638-2017%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.