# FDA recall D-0809-2018

> **Prescript Pharmaceuticals, Inc.** · Class II · drug recall initiated 2018-04-24.

## Product

Acetaminophen 300 mg with Codeine Phosphate 30 mg tablets, USP, 20-count M-Pak containers, Rx Only. Mnfct for: Mallinckrodt Inc. Hazelwood, MO 63042. Mnfct by:Mallinckrodt Inc. Hazelwood, MO 63042. Pckgd by PreScript Pharm Inc. Pleasanton, CA 94566 NDC: 00406-0484-10 Bar Code 0078-20-1834

## Reason for recall

Labeling: Not Elsewhere Classified:  due to a labeled declaration of; Store at 15¿C to 30¿C (59¿F to 86¿F) which differs from the original manufacturer declaration of; Store at 20¿C to 25¿C (68¿F to 77¿F).

## Distribution

California.

## Key facts

- **Recall number:** D-0809-2018
- **Recalling firm:** Prescript Pharmaceuticals, Inc.
- **Classification:** Class II
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2018-04-24
- **Report date:** 2018-05-23
- **Termination date:** 2019-01-23

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Pleasanton, CA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0809-2018

## Citation

> AI Analytics. FDA recall D-0809-2018. Retrieved 2026-05-26 from https://api.ai-analytics.org/recall/D-0809-2018. Source: US FDA. Licensed CC0.

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