# FDA recall D-1416-2012

> **VistaPharm, Inc.** · Class II · drug recall initiated 2012-05-30.

## 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 for recall

Impurities/Degradation Products: exceeded specification at 3 month stability testing

## Distribution

Nationwide

## Key facts

- **Recall number:** D-1416-2012
- **Recalling firm:** VistaPharm, Inc.
- **Classification:** Class II
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2012-05-30
- **Report date:** 2012-07-18
- **Termination date:** 2013-05-22

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Largo, FL, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1416-2012

## Citation

> AI Analytics. FDA recall D-1416-2012. Retrieved 2026-05-25 from https://api.ai-analytics.org/recall/D-1416-2012. Source: US FDA. Licensed CC0.

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