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
Reported: August 7, 2019 Initiated: July 12, 2019 #D-1580-2019
Product Description
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.
Details
- Recalling Firm
- H J Harkins Company Inc dba Pharma Pac
- Units Affected
- 97 boxes
- Distribution
- Distributed in California
- Location
- Grover Beach, CA
Frequently Asked Questions
What product was recalled? ▼
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. Recalled by H J Harkins Company Inc dba Pharma Pac. Units affected: 97 boxes.
Why was this product recalled? ▼
CGMPs Deviations: Insufficient Quality Assurance controls over critical systems in the manufacturing facility.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on August 7, 2019. Severity: Moderate. Recall number: D-1580-2019.
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