Amitriptyline HCl USP Recalled for Lack of Stability Data
American Pharmaceutical Ingredients is recalling Amitriptyline HCl USP for prescription compounding due to a lack of stability data 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 due to CGMP deviations regarding stability data. Per the rubric, this falls under 'voluntary precautionary recalls' or minor labeling/documentation issues where the hazard is theoretical and no illnesses are reported.
Plain-English summary
American Pharmaceutical Ingredients LLC is recalling specific lots of Amitriptyline HCl USP for prescription compounding. The product is available in 25 g, 100 g, 500 g, and 1000 g packages and is distributed nationwide within the United States. The recall involves a total of 15,000 g of the product.
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. The affected lots are identified by lot numbers 031915-1 and 031915-2, with an expiration date of 12/31/2019.
Consumers and healthcare providers should stop using the affected product and contact their pharmacist or the recalling firm for instructions on return or replacement. This recall is classified as Class II by the FDA, 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
- Amitriptyline HCl USP for prescription compounding , packaged in a) 25 g (NDC 58597-8003-4); b) 100 g (NDC 58597-8003-6); c) 500 g (NDC 58597-8003-7), d) 1000 g (NDC 58597-8003-8), RX only, packed by American Pharmaceutical Ingredients, 6650 Highland Road, Waterford, MI 48327.
- Manufacturer
- American Pharmaceutical Ingredients LLC
- Affected units
- 15,000
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 (6)
- Lot #: a) 031915-1
- Exp. 12/31/2019
- b) 031915-2
- c) 031915-2
- d) 031915-1
- Exp. 12/31/2019.
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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