The Recall Desk
ModerateFDA (Drugs)·D-1320-2022·Announced 2022-08-17

FDA recalls eye ointment for improper storage outside label specifications

GenTeal eye ointment (40 boxes, nationwide) recalled due to CGMP storage deviations. Products were stored outside drug label specifications.

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: FDA Class II recall for storage deviation without documented illnesses or adverse events. The hazard is precautionary, based on non-compliance with storage specifications rather than proven product harm.

Plain-English summary

GenTeal Tears Lubricant Eye Ointment, 3.5 gm boxes (NDC 0065-0518-01), has been recalled by McKesson Medical-Surgical Inc. Approximately 40 boxes were affected and distributed nationwide. The product is identified by Part# 30065051801.

The recall was issued due to Current Good Manufacturing Practice (CGMP) deviations. The recalled products were stored outside the conditions specified on the drug label.

Consumers who have this product should verify whether they possess any affected units and contact McKesson Medical-Surgical Inc. or the FDA for guidance on appropriate action.

The recalled product

Product
GENTEAL (MINERAL OIL, WHITE PETROLATUM)
Brand
GENTEAL
Manufacturer
Mckesson Medical-Surgical Inc. Corporate Office
Category
Drug — Ophthalmic
Hazard
  • improper-storage

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 (1)

  • Part# 30065051801

UPCs (1)

  • 0300650518017

Distribution

Distributed nationwide across the United States.

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