Valproic Acid Oral Solution Recalled for Microbial Contamination
American Health Packaging is recalling Valproic Acid Oral Solution due to potential microbial contamination in liquid sugar batches used during manufacturing. The affected product was distributed nationwide.
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: This is an FDA Class II recall involving a manufacturing deviation with potential (not confirmed) microbial contamination. No illnesses or injuries are reported in the source text, and the hazard is theoretical rather than documented. This meets the criteria for a Moderate severity recall.
Plain-English summary
American Health Packaging is recalling Valproic Acid Oral Solution, USP, 500 mg/10 mL in 100-unit dose cups per case (Case NDC #60687-262-56; Individual Dose NDC 60687-262-42) manufactured under Lot 1000082 with an expiration date of 06/30/2022.
The recall was initiated due to Current Good Manufacturing Practice (CGMP) deviations involving potential contamination with microbial organisms in liquid sugar batches used during product manufacture.
The recalled product was distributed nationwide across the United States. Patients taking this medication should consult their healthcare provider or pharmacist about the recall and whether their supply may be affected.
Consumers and healthcare providers with questions or who have received the affected lot are encouraged to contact the recalling firm or the FDA.
The recalled product
- Product
- Valproic Acid Oral Solution, USP, 500 mg/10 mL, 100 10 mL unit dose cups per case, Rx Only, Packaged and Distributed by: American Health Packaging, Columbus, Ohio 43217 Case NDC#: 60687-262-56; Individual Dose NDC: 60687-262-42
- Manufacturer
- American Health Packaging
- Category
- Drug — Oral Solution
- Affected units
- 548
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 (2)
- Lot 1000082
- Exp 06/30/2022
Distribution
Distributed nationwide across the United States.
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