# FDA recall D-1580-2019

> **H J Harkins Company Inc dba Pharma Pac** · Class II · drug recall initiated 2019-07-12.

## Product

Neomycin 3.5 mg/g / Polymyxin B10000 USP Units/g / Dexamethasone 1 mg/g Ophthalmic Ointment, 3.5 g tube, Rx only, Manufactured for H.J. Harkins Company, Inc. dba Pharma Pac by Perrigo Co, Allegan, MI 49010, NDC 52959-0407-01

## Reason for recall

CGMPs Deviations: Insufficient Quality Assurance controls over critical systems in the manufacturing facility.

## Distribution

Distributed in California

## Key facts

- **Recall number:** D-1580-2019
- **Recalling firm:** H J Harkins Company Inc dba Pharma Pac
- **Classification:** Class II
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2019-07-12
- **Report date:** 2019-08-07
- **Termination date:** 2023-06-05

- **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-1580-2019

## Citation

> AI Analytics. FDA recall D-1580-2019. Retrieved 2026-06-25 from https://api.ai-analytics.org/recall/D-1580-2019. Source: US FDA. Licensed CC0.

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