FDA Drug recall D-1580-2019
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. Har…
- FDA Drug
- Class II
- terminated
- Published 2019-08-07
On 2019-08-07 the FDA classified a Class II recall of 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. Har… by H J Harkins, citing CGMPs Deviations: Insufficient Quality Assurance controls over critical systems in the manufacturing facility.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-1580-2019 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2019-07-12 |
| Published | 2019-08-07 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | H J Harkins |
| Distribution | CA |
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
CGMPs Deviations: Insufficient Quality Assurance controls over critical systems in the manufacturing facility.
Identifiers
| code_info | Lot #: NPD10RP, Exp 08/19; NPD11RP, Exp 09/19; NPD12RP, Exp 11/19; NPD13RP, Exp 02/20; NPD14RP, Exp 02/20; NPD15RP, Exp…Lot #: NPD10RP, Exp 08/19; NPD11RP, Exp 09/19; NPD12RP, Exp 11/19; NPD13RP, Exp 02/20; NPD14RP, Exp 02/20; NPD15RP, Exp 05/20; NPD16RP, Exp 06/20; NPD17RP, Exp 01/21; NPD18RP, Exp 02/21 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-1580-2019%22
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