Preferred Pharmaceuticals Recalls Neomycin Ophthalmic Ointment for Quality Control Issues
Preferred Pharmaceuticals is recalling 171 tubes of Neomycin Sulfate/Polymyxin B/Dexamethasone Ophthalmic Ointment due to insufficient quality assurance controls.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
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 due to CGMP deviations and insufficient quality assurance controls, which fits the rubric for moderate severity involving low-risk contamination or voluntary precautionary measures without reported injuries.
Plain-English summary
Preferred Pharmaceuticals, Inc. is recalling 171 tubes of Neomycin Sulfate 3.5 mg/Polymyxin B Sulfate 10,000 units/Dexamethasone 1 mg Ophthalmic Ointment. The product is a generic version of Maxitrol, packaged in 3 g tubes, and is intended for external use only. The recall was initiated due to deviations from Current Good Manufacturing Practices (CGMPs), specifically insufficient quality assurance controls over critical systems in the manufacturing facility.
The affected product was distributed in California and Florida. The recall covers specific lots with expiration dates ranging from September 2019 to May 2020. The manufacturer is Paddock Laboratories, LLC, and the product is marketed by Preferred Pharmaceuticals, Inc. and The Physicians Solutions in Anaheim, CA.
Consumers and healthcare providers should stop using the recalled product and return it to the pharmacy or point of purchase. The FDA classifies this as a Class II recall, indicating a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences.
The recalled product
- Product
- Neomycin Sulfate 3.5 mg/Polymyxin B Sulfate 10,000 units/Dexamethasone 1 mg Ophthalmic Ointment, Pkg Size 3 g Tube, Generic for: Maxitrol, For External Use Only, Rx only, Mfg: Paddock Laboratories, LLC, Preferred Pharmaceuticals, Inc., The Physicians Solutions, Anaheim, CA, NDC…
- Manufacturer
- Preferred Pharmaceuticals, Inc
- Category
- Drug — Ophthalmic Ointment
- Affected units
- 171
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 (9)
- Lot #: L2117Q
- Batch: 12211717
- Exp. 09/2019
- F2818H
- Batch: 06281808
- Exp. 11/2019
- B1819T
- Batch: B1819T001 to B1819T048 (Inclusive)
- Exp. 05/2020.
Distribution
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