FDA Drug recall D-1416-2012
Hydrocodone Bitartrate & Acetaminophen Oral Solution 7.5 mg/325 mg per 15 mL, a) 15 mL Unit Dose Cups (50 unit dose cups per case), b) 473…
- FDA Drug
- Class II
- terminated
- Published 2012-07-18
On 2012-07-18 the FDA classified a Class II recall of Hydrocodone Bitartrate & Acetaminophen Oral Solution 7.5 mg/325 mg per 15 mL, a) 15 mL Unit Dose Cups (50 unit dose cups per case), b) 473… by Vistapharm, citing impurities/Degradation Products: exceeded specification at 3 month stability testing.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-1416-2012 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2012-05-30 |
| Published | 2012-07-18 |
| Last updated | 2026-09-13 11:51 UTC |
| Company | Vistapharm |
| Distribution | US |
Product
Hydrocodone Bitartrate & Acetaminophen Oral Solution 7.5 mg/325 mg per 15 mL, a) 15 mL Unit Dose Cups (50 unit dose cups per case), b) 473 mL Bottles, C III, Rx Only, Warning May be habit forming, Manufactured by VistaPharm, Largo, FL 33771, NDC a) 66689-023-50, b) NDC 66689-023-16.
Reason
Impurities/Degradation Products: exceeded specification at 3 month stability testing
Identifiers
| code_info | Lot #'s a) 251400, Exp 07/13; b) 251500 Exp 07/13. |
|---|
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-1416-2012%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.