# FDA recall D-0806-2016

> **Meditech Laboratories, Inc** · Class II · drug recall initiated 2016-03-14.

## Product

Formula 3 (Papaverine 20 mg, Phentolamine 3 mg, Atropine 0.2 mg, PGE 20 mcg/mL) Injection, 5 mL vials, Rx only, Meditech Laboratories, Inc., 3200 Polaris Ave., Suite 27, Las Vegas, NV  89102.

## Reason for recall

Stability Does Not Support Expiry: manufactured with an active ingredient that expired before the labeled Beyond Use Date.

## Distribution

Nationwide

## Key facts

- **Recall number:** D-0806-2016
- **Recalling firm:** Meditech Laboratories, Inc
- **Classification:** Class II
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2016-03-14
- **Report date:** 2016-04-13
- **Termination date:** 2016-06-07

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Las Vegas, NV, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0806-2016

## Citation

> AI Analytics. FDA recall D-0806-2016. Retrieved 2026-05-23 from https://api.ai-analytics.org/recall/D-0806-2016. Source: US FDA. Licensed CC0.

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