The Recall Desk
ModerateFDA (Drugs)·D-0551-2021·Announced 2021-06-02

Cardinal Health Recalls Triamcinolone Acetonide Ointment Due to Temperature Excursions

Cardinal Health Inc. is recalling 178 tubes of Triamcinolone Acetonide Ointment, 0.025%, due to intermittent exposure to temperature excursions during storage.

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, which typically involves situations where use may cause temporary or medically reversible health consequences. The hazard is a storage temperature excursion, which is a quality control issue rather than a direct acute hazard like contamination or mislabeling of a common allergen.

Plain-English summary

Cardinal Health Inc. is recalling 178 tubes of Triamcinolone Acetonide Ointment, USP, 0.025% (80g). The product is a prescription-only topical corticosteroid distributed by Perrigo in Allegan, Michigan. The specific NDC for the recalled product is 45802-054-36.

The recall was initiated due to Current Good Manufacturing Practice (CGMP) deviations, specifically intermittent exposure to temperature excursions during storage. This condition may affect the stability or quality of the medication.

The affected product was distributed in Florida, Georgia, and South Carolina. Consumers and healthcare providers should stop using the recalled product and contact their pharmacist or healthcare provider for a replacement or further instructions.

The recalled product

Product
TRIAMCINOLONE ACETONIDE (TRIAMCINOLONE ACETONIDE)
Brand
TRIAMCINOLONE ACETONIDE
Affected units
178

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)

  • 0MT0286

Distribution

Distributed in 3 states:

Part of a larger recall action

This product is one of 198 recalled by Cardinal Health Inc. 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 198 products in this recall →