Class II · Moderate risk
Valproic Acid Oral Solution
CGMP Deviations: Firm went out of business and could no longer continue stability studies.
Valproic Acid Oral Solution
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Why it was recalled
CGMP Deviations: Potential concern with products manufactured using liquid sugar batches contaminated with microbial organisms.
Cause type: Microbial contamination
Bacteria, mold, yeast or other microorganisms detected in the product. Contamination can occur from water systems, equipment or handling, and can cause infection. All microbial contamination recalls.
What was recalled
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
Affected NDCs
60687-0262-42
60687-0262-56
Compare with the code on your package — it is the most precise check available.
Drug: Valproic
- Recalling firm
- American Health Packaging
- Origin
- OH, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0854-2021 · FDA notice
Check, then ask. Class II means harm is possible but usually temporary or reversible. Find the lot number on your package; if it matches, ask your pharmacist about a replacement. Do not simply stop a prescribed medication on your own - the gap can be riskier than the recall. This recall is now terminated, which means the firm has finished removing the affected product; anything on pharmacy shelves today should be unaffected.
Other Valproic recalls
See all
Class II · Moderate risk
Valproic Acid Oral Solution USP
CGMP Deviations: Potential concern with products manufactured using liquid sugar batches contaminated with microbial organisms.
Class II · Moderate risk
Divalproex Sodium Extended-Release Tablets
Failed Dissolution Specifications; exceeded specification at the 9 hour time point
Class III · Low risk
Divalproex Sodium Delayed-Release Tablets
Labeling: Label Error On Declared Strength; Some bottles of product were missing the color-coded strength on the primary display panel of the label.
Other recalls by American Health Packaging
All 2021 recalls
Class III · Low risk
Buprenorphine Sublingual Tablets
Labeling: Label Mix-up
Class III · Low risk
Nitrofurantoin Capsules
Failed Dissolution Specifications: Nitrofurantoin Capsules recalled due to dissolution failure at 0-time of the repackaged lot. Drug release results were above specification at 0-time.
Class III · Low risk
Cyanocobalamin Injection
Subpotent Drug: Out of specification for assay.
Class II · Moderate risk
Oxycodone Hydrochloride Oral Solution
Impurity failure at 0-time of the repackaged lot.
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