American Pharmaceutical Ingredients Recalls Levothyroxine Sodium Due to Stability Data Deficiencies
American Pharmaceutical Ingredients LLC is recalling specific lots of Levothyroxine Sodium USP for prescription compounding due to a lack of stability data and controls to support the assigned expiration dates.
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 corresponds to a moderate severity score. The hazard involves a lack of stability data and controls, which is a quality control issue rather than a direct, reported health threat like a high-risk pathogen or structural defect.
Plain-English summary
American Pharmaceutical Ingredients LLC is voluntarily recalling specific lots of Levothyroxine Sodium USP for prescription compounding. The affected product is packaged in 1g and 5g containers and is intended for prescription use only. The recall involves Lot # 090517B-2 with an expiration date of 11/17/2019.
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.
The product was distributed nationwide within the United States. Consumers and healthcare providers should discontinue use of the affected lots and contact their pharmacist or the recalling firm for further instructions.
The recalled product
- Product
- Levothyroxine Sodium USP for prescription compounding, packaged in a) 1g (NDC 58597-8638-1); b) 5 g (NDC 58597-8638-2), 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
- 75
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) 090517B-2
- Exp. 11/17/2019
- b) 090517B-2
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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