Neomycin 3 — Class II drug recall D-1580-2019
Terminated recall by H J Harkins Company Inc dba Pharma Pac, reported 2019-08-07, distributed in CA. CGMPs Deviations: Insufficient Quality Assurance controls over critical systems in the manufacturing facility.
| Recall number | D-1580-2019 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | H J Harkins Company Inc dba Pharma Pac, Grover Beach, CA, United States |
| Recall initiated | 2019-07-12 |
| Classified | 2019-07-31 |
| Reported by FDA | 2019-08-07 |
| Terminated | 2023-06-05 |
| Distributed | CA |
| Quantity | 97 boxes |
| NDC | 52959-0407-01 |
| Lot numbers | 01/21, 02/20, 02/21, 05/20, 06/20, 08/19, 09/19, 11/19, NPD10RP, NPD11RP, NPD12RP, NPD13RP, NPD14RP, NPD15RP, NPD16RP, NPD17RP, NPD18RP |
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-1580-2019. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.