The Recall Desk
ModerateFDA (Drugs)·D-0567-2021·Announced 2021-06-02

Cardinal Health Recalls Collagenase Santyl Ointment Due to Temperature Excursions

Cardinal Health is recalling 1,391 tubes of Collagenase Santyl Ointment due to intermittent 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 indicates a situation where use of the product may cause temporary or medically reversible health consequences. The hazard is a CGMP deviation (temperature excursion) without reported illnesses, fitting the 'Moderate' criteria for low-risk contamination or voluntary precautionary recalls.

Plain-English summary

Cardinal Health Inc. is recalling 1,391 tubes of Collagenase Santyl Ointment, 250 units/g, 30 grams. The product is marketed by Smith & Nephew, Inc. and is a prescription-only topical medication. The recall was initiated due to CGMP deviations involving intermittent exposure to temperature excursions during storage.

The affected product is identified by code 191960 and NDC 50484-010-30. Distribution was limited to Florida, Georgia, and South Carolina. The source text does not specify the exact dates of distribution or the specific facilities where the product was sold.

Consumers and healthcare providers should stop using the recalled product and contact their pharmacist or healthcare provider for instructions on how to return or dispose of the medication. No illnesses or injuries have been reported in connection with this recall.

The recalled product

Product
COLLAGENASE SANTYL (COLLAGENASE SANTYL)
Brand
COLLAGENASE SANTYL
Manufacturer
Cardinal Health Inc.
Category
Drug — Topical Prescription Ointment
Hazard
Affected units
1,391

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)

  • 191960

UPCs (1)

  • 0350484010300

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 →

Related recalls

Same manufacturer · Cardinal Health Inc.

See all →

Same hazard · temperature excursion

See all →