FDA recall D-1580-2019

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

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

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1580-2019