# FDA recall D-1246-2020

> **H J Harkins Company Inc dba Pharma Pac** · Class II · drug recall initiated 2020-04-15.

## Product

Acetaminophen and Codeine Phosphate 300/30 mg tablet, packaged in: a) 10-count bottle (NDC 52959-0003-10), b) 12-count bottle (NDC 52959-0003-12), c) 14-count bottle (NDC 52959-0003-14), d) 15-count bottle (NDC 52959-0003-15), e) 16-count bottle (NDC 52959-0003-16), f) 20-count bottle (NDC 52959-0003-20), g) 30-count bottle (NDC 52959-0003-30), h) 60-count bottle (NDC 52959-0003-60), Rx Only, Mfg. Aurobindo; Repack: H.J. Harkins Co., Inc., Grover Beach, CA 93433

## Reason for recall

cGMP Deviations

## Distribution

Product was distributed in CA and AZ.

## Key facts

- **Recall number:** D-1246-2020
- **Recalling firm:** H J Harkins Company Inc dba Pharma Pac
- **Classification:** Class II
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2020-04-15
- **Report date:** 2020-04-22
- **Termination date:** 2024-02-14

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

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1246-2020

## Citation

> AI Analytics. FDA recall D-1246-2020. Retrieved 2026-06-09 from https://api.ai-analytics.org/recall/D-1246-2020. Source: US FDA. Licensed CC0.

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