Ursodiol USP Recall Due to Missing Stability Data and Expiration Controls
American Pharmaceutical Ingredients is recalling Ursodiol USP for prescription compounding due to a lack of stability data and controls supporting the assigned expiration dates.
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 might cause temporary or medically reversible health consequences. The hazard is a documentation and stability control issue rather than a direct contamination or acute injury risk.
Plain-English summary
American Pharmaceutical Ingredients LLC is recalling Ursodiol USP for prescription compounding. The product is available in 100g and 500g packages and is distributed nationwide within the United States. The specific lot number is 071316-1, with an expiration date of 05/27/2019.
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 dates for the product in its container/closure system.
This recall affects pharmacies and compounding facilities that may have purchased the product. Consumers should not use the recalled product and should contact their pharmacist or healthcare provider for guidance on alternative treatments or replacements.
The recalled product
- Product
- Ursodiol USP for prescription compounding, packaged in a) 100g (NDC 58597-8038-6); b) 500g (NDC 58597-8038-7), 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
- 25,000
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) 071316-1
- Exp. 05/27/2019
- b) 071316-1
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 →Related recalls
Same manufacturer · American Pharmaceutical Ingredients LLC
See all →- ModerateAmerican Pharmaceutical Ingredients Recalls Sermorelin Acetate Powder Due to Stability Data
FDA (Drugs) · 2018-03-21
- ModerateOxytocin USP Powder Recalled Due to Insufficient Stability Data
FDA (Drugs) · 2018-03-21
- ModerateFDA Recalls Testosterone Cypionate Due to Missing Stability Data
FDA (Drugs) · 2018-02-28
- ModerateLevofloxacin Hemihydrate Recalled for Lack of Stability Data
FDA (Drugs) · 2018-02-28
- ModerateFDA Recalls Doxycycline Hyclate Due to Missing Stability Data
FDA (Drugs) · 2018-02-28
Same hazard · stability data
See all →- ModerateKalchem Recalls Vardenafil HCl Due to Missing Stability Data
FDA (Drugs) · 2018-03-14
- SevereApollo Care Recalls Vancomycin IV Bags Due to Stability Data Issues
FDA (Drugs) · 2018-03-14
- ModerateNandrolone Decanoate USP Recalled for Lack of Stability Data
FDA (Drugs) · 2018-02-28
- ModerateCyclobenzaprine HCl USP Recalled for Lack of Stability Data
FDA (Drugs) · 2018-02-28