Spirit Pharmaceuticals Recalls Valumeds Ibuprofen Due to CGMP Deviations
Spirit Pharmaceuticals is recalling 144 bottles of Valumeds Ibuprofen 200 mg in New York due to Current Good Manufacturing Practice (CGMP) deviations.
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, and the source text does not report any illnesses, injuries, or deaths, fitting the criteria for a moderate severity score.
Plain-English summary
Spirit Pharmaceuticals, LLC is recalling 144 bottles of Valumeds Ibuprofen Tablets USP, 200 mg, 100-count bottles. The product is an over-the-counter medication distributed in New York. The specific lot number is HJ6138, and the NDC is 68210-0800-1.
The recall is being conducted in response to Current Good Manufacturing Practice (CGMP) deviations. The source text notes that this action is taken in response to a previous recall. No specific illnesses, injuries, or deaths are reported in the provided text.
Consumers who have this product should stop using it and contact their healthcare provider or the recalling firm for further instructions. The product was distributed in New York.
The recalled product
- Product
- VALUMEDS IBUPROFEN (IBUPROFEN)
- Brand
- VALUMEDS IBUPROFEN
- Manufacturer
- Spirit Pharmaceuticals, LLC
- Category
- Drug — OTC Pain Reliever
- Hazard
- Affected units
- 144
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 (1)
- Lot#: HJ6138
Distribution
Distributed in 1 state:
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