The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Drugs)·D-0568-2021·Announced 2021-06-02

Cardinal Health Recalls Clindamycin Hydrochloride Capsules Due to Temperature Excursions

Cardinal Health Inc. is recalling 223 bottles of Clindamycin Hydrochloride 150mg capsules due to intermittent temperature excursions during storage.

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 2/5 (Moderate).

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 due to CGMP deviations (temperature excursions) without reported illnesses or injuries, fitting the criteria for moderate severity involving low-risk contamination or voluntary precautionary measures.

Plain-English summary

Cardinal Health Inc. is recalling 223 bottles of Clindamycin Hydrochloride Capsules, USP, 150mg, 100-count bottles. The product is a prescription-only medication manufactured by Ohm Laboratories Inc. and distributed by Sun Pharmaceutical Industries, Inc. The specific lot code for the recalled product is AB77104.

The recall was initiated due to Current Good Manufacturing Practice (CGMP) deviations, specifically intermittent exposure to temperature excursions during storage. The affected product was distributed in Florida, Georgia, and South Carolina.

Consumers who have this product should stop using it and contact their healthcare provider or pharmacist for guidance. The recall is classified as FDA Class II, indicating a situation where use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences.

The recalled product

Product
CLINDAMYCIN HYDROCHLORIDE (CLINDAMYCIN HYDROCHLORIDE)
Brand
CLINDAMYCIN HYDROCHLORIDE
Manufacturer
Cardinal Health Inc.
Category
Drug — Antibiotic
Hazard
Affected units
223

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)

  • AB77104

UPCs (1)

  • 0363304693010

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 →

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