American Pharmaceutical Ingredients Recalls Ascorbic Acid Due to Stability Data Gaps
American Pharmaceutical Ingredients LLC is recalling Ascorbic Acid USP for prescription compounding because it lacks stability data to support its 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, which fits the rubric for moderate severity involving labeling or documentation issues without reported injuries.
Plain-English summary
American Pharmaceutical Ingredients LLC is recalling Ascorbic Acid USP, a raw ingredient used for prescription compounding, in 100g, 500g, 1000g, 5000g, and 25000g packages. The recall is due to Current Good Manufacturing Practice (CGMP) deviations, specifically the lack of stability data and controls to support the manufacturer's assigned retest or expiration dates in the firm's container/closure system.
The affected product is distributed nationwide within the USA. Specific lot numbers and expiration dates are listed in the recall documentation, with expiration dates of 05/20/2018 for the identified lots. The product is intended for prescription use only.
Consumers and healthcare providers should stop using the affected product and contact the recalling firm or their healthcare provider for further instructions. The FDA has classified this recall as Class II, indicating a reasonable probability that the use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences.
The recalled product
- Product
- Ascorbic Acid USP, for prescription compounding, packaged in a) 100g (NDC 58597-8120-6); b) 500g (NDC 58597-8120-7); c) 1000g (NDC 58597-8120-8); d) 5000g (NDC 58597-8120-9); e) 25000g (NDC 58597-8120-3), RX only, packed by American Pharmaceutical Ingredients, LLC 6650 Highland R
- Manufacturer
- American Pharmaceutical Ingredients LLC
- Category
- Drug — Pharmaceutical Ingredient
- Affected units
- 200,000
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 #: b) 030816-1
- Exp. 05/20/2018
- c) 030816-1
- d) 030816-3
- e) 030816-2
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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