FDA Drug recall D-0458-2017
Hydrocodone Bitartrate and Acetaminophen Oral Solution, 7.5 mg/325 mg per 15 mL C-II, a) 4 fl.oz .(120 mL), 12 bottles per case (NDC 66689-…
- FDA Drug
- Class II
- terminated
- Published 2017-02-08
On 2017-02-08 the FDA classified a Class II recall of Hydrocodone Bitartrate and Acetaminophen Oral Solution, 7.5 mg/325 mg per 15 mL C-II, a) 4 fl.oz .(120 mL), 12 bottles per case (NDC 66689-… by Vistapharm, citing CGMP Deviations: Purified water used to manufacture the drug products may have been contaminated with Burkholderia cepacia.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0458-2017 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2017-01-18 |
| Published | 2017-02-08 |
| Last updated | 2026-09-13 11:51 UTC |
| Company | Vistapharm |
| Distribution | US |
Product
Hydrocodone Bitartrate and Acetaminophen Oral Solution, 7.5 mg/325 mg per 15 mL C-II, a) 4 fl.oz .(120 mL), 12 bottles per case (NDC 66689-023-04), b) 16 fl.oz. (473 mL), 12 bottles per case (NDC 66689-023-16), c) 50 unit dose cups of 15 mL per case, (NDC No. 66689-023-50), Rx only, Manufactured by VistaPharm, Largo, FL 33771
Reason
CGMP Deviations: Purified water used to manufacture the drug products may have been contaminated with Burkholderia cepacia.
Identifiers
| code_info | a). Lot No. 419000 (Exp. 03/17) b.) Lot No. 419800 (Exp. 03/17), 429100 (Exp. 06/17) c). Lot No. 418200 (Exp. 03/17)…a). Lot No. 419000 (Exp. 03/17) b.) Lot No. 419800 (Exp. 03/17), 429100 (Exp. 06/17) c). Lot No. 418200 (Exp. 03/17), 430100 (Exp. 06/17), 423800 (Exp. 04/17), 413100 (Exp. 02/17), 410700 (Exp. 01/17) |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:51 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0458-2017%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.