Clonidine HCl USP Recalled Due to Missing Stability Data
American Pharmaceutical Ingredients LLC is recalling Clonidine HCl 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 situation where use of the product may cause temporary or medically reversible adverse health consequences. The hazard is a CGMP deviation regarding stability data rather than a confirmed contamination or injury.
Plain-English summary
American Pharmaceutical Ingredients LLC is recalling Clonidine HCl USP for prescription compounding. The product is available in 5g, 10g, 25g, and 100g packages and is intended for prescription use only. The recall covers 5,000 g of the product distributed nationwide within the USA.
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 product is identified by Lot # 070915-1 with an expiration date of 12/31/2019. Consumers and healthcare providers should stop using the recalled product and contact their pharmacist or the recalling firm for further instructions.
The recalled product
- Product
- Clonidine HCl USP for prescription compounding, packaged in a) 5g (NDC 58597-8010-2); b) 10g (NDC 58597-8010-3); c) 25g (NDC 58597-8010-4); d)100g (NDC 58597-8010-6), 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
- 5,000
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 (5)
- Lot #: a) 070915-1
- Exp. 12/31/2019
- b) 070915-1
- c) 070915-1
- d) 070915-1
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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