Pentoxifylline USP Recalled Due to Missing Stability Data
American Pharmaceutical Ingredients LLC is recalling Pentoxifylline USP for prescription compounding because it lacks stability data to support its expiration date.
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 temporary or medically reversible adverse health consequence. The hazard is a documentation and stability data deficiency rather than a confirmed contamination or acute safety failure, fitting the Moderate severity criteria for minor labeling or documentation issues.
Plain-English summary
American Pharmaceutical Ingredients LLC is recalling Pentoxifylline USP for prescription compounding. The product is available in 25g and 100g packages and is intended for prescription use only. The recall affects approximately 29,550 grams of the product, distributed nationwide within the United States.
The recall was initiated due to Current Good Manufacturing Practice (CGMP) deviations. Specifically, the manufacturer lacked the necessary stability data and controls to support the assigned retest or expiration date for the product in its container/closure system. The affected lot number is 092515-1, with an expiration date of May 31, 2020.
Healthcare professionals and pharmacies should stop using the recalled product and contact the recalling firm for instructions on how to return it. Consumers should not use the product and should consult their healthcare provider if they have questions regarding their medication.
The recalled product
- Product
- Pentoxifylline USP for prescription compounding, packaged in a) 25g (NDC 58597-8429-4); b) 100g (NDC 58597-8429-6), RX only, packed by American Pharmaceutical Ingredients, LLC 6650 Highland Road, Waterford, MI 48327
- Manufacturer
- American Pharmaceutical Ingredients LLC
- Category
- Drug — Pharmaceutical Ingredient
- Affected units
- 29,550
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 (4)
- Lot #: a) 092515-1
- Exp. 5/31/2020
- b) 092515-1
- Exp. 5/31/2020.
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.
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