# FDA recall D-0108-2018

> **Teva Pharmaceuticals USA** · Class III · drug recall initiated 2017-11-28.

## Product

Penicillin V Potassium for Oral Solution, USP, 125 mg (200,000 U) per 5 mL, 100 mL (when mixed) bottle, Rx only, Manufactured In Canada By: Teva Canada Limited, Toronto, Canada M1B 2K9; Manufactured For: Teva Pharmaceuticals USA, Inc., North Wales, PA 19454; NDC 0093-4125-73.

## Reason for recall

Failed Impurities/Degradation Specifications: high out of specification test results obtained for individual and total impurities.

## Distribution

Nationwide in the USA and Puerto Rico.

## Key facts

- **Recall number:** D-0108-2018
- **Recalling firm:** Teva Pharmaceuticals USA
- **Classification:** Class III
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2017-11-28
- **Report date:** 2017-12-20
- **Termination date:** 2018-07-03

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** North Wales, PA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0108-2018

## Citation

> AI Analytics. FDA recall D-0108-2018. Retrieved 2026-06-01 from https://api.ai-analytics.org/recall/D-0108-2018. Source: US FDA. Licensed CC0.

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