Baclofen USP Micronized Recalled for Lack of Stability Data
American Pharmaceutical Ingredients LLC is recalling Baclofen USP (Micronized) for prescription compounding due to a lack of stability data supporting 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, but the source text does not report any illnesses, injuries, or hospitalizations. The hazard is a CGMP deviation regarding stability data, which fits the criteria for a moderate severity score involving low-risk contamination or voluntary precautionary measures without reported harm.
Plain-English summary
American Pharmaceutical Ingredients LLC is recalling Baclofen USP (Micronized) for prescription compounding. The product is available in 25g, 100g, 500g, and 1000g packages and is distributed nationwide within the USA. The recall involves specific lot numbers and expiration dates ranging from August 2018 to January 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 is classified as an FDA Class II recall.
Healthcare professionals and pharmacies should stop using the affected lots of Baclofen USP (Micronized) and contact the recalling firm for instructions on return or disposal. Patients should consult their healthcare providers regarding alternative medications if they have been prescribed this specific ingredient for compounding.
The recalled product
- Product
- Baclofen USP (Micronized) for prescription compounding, packaged in a) 25g (NDC 58597-8004-4); b)100g (NDC 58597-8004-6); c) 500g (NDC 58597-8004-7); d) 1000g (NDC 58597-8004-8), RX only, packed by American Pharmaceutical Ingredients, 6650 Highland Road, Waterford, MI 48327.
- Manufacturer
- American Pharmaceutical Ingredients LLC
- Category
- Drug — Pharmaceutical Ingredient
- Affected units
- 55,500
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 (10)
- Lot #: a) 021816-2
- 021816-3
- Exp. 08/24/2018
- 70616-1
- Exp. 01/31/2019
- b) 021816-1
- 070616-1
- c) 021816-1
- d) 021816-1
- exp. 01/31/2019.
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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