FDA-Drug2026-09-30Class IIPROCESSING DEFECT
Major LubriFresh P.M. Nighttime Ointment recalled for lack of sterility assurance
What this means
Major Pharmaceuticals is recalling LubriFresh P.M. Nighttime Ointment (0.125 oz tubes, Lot #3183) because the manufacturer cannot confirm the product meets sterility standards. This means the product may not be free from unwanted microorganisms.
- Check if you have LubriFresh P.M. Nighttime Ointment with Lot #3183 (printed on the tube).
- Stop using this product if you have it.
- Contact Major Pharmaceuticals or your pharmacy for a refund or replacement.
- Consult your doctor if you have any health concerns after using this product.
The agency's original wording
Hazard
Lack of Assurance of Sterility
Intended for
Adults
Illnesses reported
None reported
Sold states
USA Nationwide
Affected count
34368 tubes
Manufactured in
109 S 2nd St, Dupo, IL, United States
Products
Major LubriFresh P.M. Nighttime Ointment, Net wt. 0.125 oz. (3.5 g) tubes, Distributed by: Major Pharmaceuticals, 17177 N Laurel Park Drive, Suite 233, Livonia, MI 48152, NDC 0904-6488-38
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0861-2026More Sterling Pharmaceutical Services recalls
- FDA-Drug2026-09-30Reliable-1 Laboratories Lubricating Tears recalled for lack of sterility assurance
- FDA-Drug2026-09-30Walgreens Lubricant Eye Drops recalled for lack of sterility assurance
- FDA-Drug2026-09-30Reliable-1 Laboratories Sodium Chloride 5% eye solution recalled for sterility assurance
- FDA-Drug2026-09-30Walgreens Lubricant Eye Drops recalled for lack of sterility assurance
- FDA-Drug2026-09-30Cameron Pharmaceuticals lubricant eye drops recalled for lack of sterility assurance
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