Agency classClass IIOur severity:High FDA (Drugs)·D-1160-2023·Announced 2023-09-27

FDA Recalls Eye Ointment Product Due to Sterility Assurance Failure

The FDA is recalling Major LubriFresh PM eye ointment due to lack of assurance of sterility. Approximately 282,564 units were distributed to accounts in Rhode Island and Colorado.

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 3/5 (High).

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: This is an FDA Class II recall of a sterile ophthalmic product without reported illnesses or injuries. While the lack of sterility assurance on an eye ointment presents a potential risk of infection, no actual contamination or adverse events have been reported in the source, warranting a High rating for this precautionary recall.

Plain-English summary

The FDA is recalling Major LubriFresh PM Nighttime Ointment, a sterile eye lubricant manufactured by Amman Pharmaceutical Industries. The product contains mineral oil and white petrolatum and is available in 0.125 ounce (3.5 gram) tubes with NDC 0904-6488-38.

The recall is due to lack of assurance of sterility. Approximately 282,564 units were distributed to accounts in Rhode Island and Colorado. The affected lots are 184001, 184002, and 184003 (expiration 11/24) and lots 184004, 184005, and 184006 (expiration 12/24).

Consumers who have purchased this product should discontinue use. Patients with questions should contact their healthcare provider or pharmacist.

The recalled product

Product: MAJOR LubriFresh P.M. Nighttime Ointment, Lubricant Eye Ointment, Sterile, 0.125 OZ (3.5g), Distributed by: MAJOR PHARMACEUTICALS, Indianapolis, IN 46268, Made in Jordan, NDC: 0904-6488-38.
Manufacturer: AMMAN PHARMACEUTICAL INDUSTRIES
Category: Drug — Ophthalmic
Hazard: lack-of-sterility
infection-risk
Affected units: 282,564

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 (6)

Lot: 184001 EXP: 11/24
184002 EXP: 11/24
184003 EXP: 11/24
Lot: 184004 EXP: 12/24
Lot: 184005 EXP: 12/24
Lot:184006 EXP:12/24

Distribution

Distributed in 2 states:

Part of a larger recall action

This product is one of 17 recalled by AMMAN PHARMACEUTICAL INDUSTRIES under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 17 products in this recall →

Same manufacturer · AMMAN PHARMACEUTICAL INDUSTRIES

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