Agency classClass IIOur severity:Moderate FDA (Drugs)·D-0479-2018·Announced 2018-02-28

FDA Recalls Clindamycin Phosphate Due to Missing Stability Data

American Pharmaceutical Ingredients LLC is recalling Clindamycin Phosphate USP for prescription compounding because the manufacturer lacks stability data to support the assigned expiration dates.

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, which typically indicates a situation where use of the product might cause temporary or medically reversible health consequences. The hazard is a documentation and stability data issue rather than a confirmed contamination or injury, fitting the Moderate severity criteria for minor labeling or data errors.

Plain-English summary

The U.S. Food and Drug Administration (FDA) has issued a recall for Clindamycin Phosphate USP intended for prescription compounding. The product is packaged in 10g and 100g containers and is distributed nationwide within the United States. The recall is initiated by American Pharmaceutical Ingredients LLC.

The reason for the recall is a Current Good Manufacturing Practice (CGMP) deviation. Specifically, the manufacturer lacks the necessary stability data and controls to support the retest or expiration dates assigned to the product in its container/closure system. This means the assigned expiration dates may not be valid.

The affected product is identified by Lot # 042315-1 with an expiration date of 03/12/2018. The NDC numbers are 58597-8198-3 for the 10g package and 58597-8198-6 for the 100g package. Consumers and healthcare providers should stop using this product and contact their pharmacist or the recalling firm for further instructions.

The recalled product

Product: Clindamycin Phosphate USP for prescription compounding, packaged in a) 10g (NDC 58597-8198-3); b) 100g (NDC 58597-8198-6), RX only, packed by American Pharmaceutical Ingredients, LLC 6650 Highland Road, Waterford, MI 48327
Manufacturer: American Pharmaceutical Ingredients LLC
Category: Drug — Pharmaceutical Ingredient
Hazard: stability-data
expiration-date
Affected units: 1,300

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 (3)

Lot #: a) 042315-1
Exp. 03/12/2018
b) 042315-1

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 66 recalled by American Pharmaceutical Ingredients LLC 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 66 products in this recall →

Same manufacturer · American Pharmaceutical Ingredients LLC

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