Levocetirizine Dihydrochloride Recalled for Lack of Stability Data
American Pharmaceutical Ingredients LLC is recalling Levocetirizine Dihydrochloride for prescription compounding due to a lack of stability data supporting the expiration date.
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, and the source text describes a CGMP deviation regarding stability data without reporting any illnesses or injuries, fitting the criteria for a moderate severity score.
Plain-English summary
American Pharmaceutical Ingredients LLC is recalling 5,800 grams of Levocetirizine Dihydrochloride for prescription compounding. The product is available in 25g and 100g packages and is distributed nationwide within the United States. The specific lot number is 073115-1, with an expiration date of 6/30/2020.
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.
This product is for prescription use only. Consumers and healthcare providers should stop using the recalled product and contact their pharmacist or healthcare provider for guidance on disposal or replacement.
The recalled product
- Product
- Levocetirizine Dihydrochloride for prescription compounding, packaged in a) 25g (NDC 58597-8355-6); b) 100g (NDC 58597-8355-6), 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
- 5,800
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) 073115-1
- Exp. 6/30/2020
- b) 073115-1
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.
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