Pharma Pac Recalls Neomycin Ophthalmic Ointment for Quality Control Issues
Pharma Pac is recalling specific lots of Neomycin Ophthalmic Ointment due to insufficient quality assurance controls in the manufacturing facility.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, and the source text cites manufacturing quality assurance deviations without reporting specific illnesses, injuries, or hospitalizations, fitting the criteria for a moderate severity precautionary recall.
Plain-English summary
H.J. Harkins Company, Inc. dba Pharma Pac is recalling 97 boxes of Neomycin 3.5 mg/g / Polymyxin B 10000 USP Units/g / Dexamethasone 1 mg/g Ophthalmic Ointment, 3.5 g tube. The product is prescription-only and was distributed in California. The recall involves specific lots with expiration dates ranging from August 2019 to February 2021.
The recall was initiated due to deviations from Current Good Manufacturing Practices (CGMPs). Specifically, there were insufficient quality assurance controls over critical systems in the manufacturing facility. This classification is designated as FDA Class II.
Consumers and healthcare providers should stop using the affected product and contact their healthcare provider for guidance. The affected lots are identified by specific lot numbers and expiration dates listed in the recall notice.
The recalled product
- 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
- Manufacturer
- H J Harkins Company Inc dba Pharma Pac
- Category
- Drug — Ophthalmic Ointment
- Affected units
- 97
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (17)
- Lot #: NPD10RP
- Exp 08/19
- NPD11RP
- Exp 09/19
- NPD12RP
- Exp 11/19
- NPD13RP
- Exp 02/20
- NPD14RP
- NPD15RP
- Exp 05/20
- NPD16RP
- Exp 06/20
- NPD17RP
- Exp 01/21
- NPD18RP
- Exp 02/21
Distribution
Distributed in 1 state:
Related recalls
Same manufacturer · H J Harkins Company Inc dba Pharma Pac
See all →- ModerateFDA Recalls Acetaminophen and Codeine Tablets Due to Manufacturing Deviations
FDA (Drugs) · 2020-04-22
- HighAcetaminophen Tablets Recalled Due to Foreign Tablet Contamination
FDA (Drugs) · 2020-03-18
- SevereRanitidine Tablets Recalled Due to NDMA Impurity Detection
FDA (Drugs) · 2020-01-29
- SevereAcetaminophen Children's Liquid Recalled for Microbial Contamination Risk
FDA (Drugs) · 2019-07-03
- SevereDiphenhydramine Liquid Recalled for Potential Microbial Contamination
FDA (Drugs) · 2019-07-03