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
Reported: October 6, 2021 Initiated: September 15, 2021 #D-0854-2021
Product Description
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
Reason for Recall
CGMP Deviations: Potential concern with products manufactured using liquid sugar batches contaminated with microbial organisms.
Details
- Recalling Firm
- American Health Packaging
- Units Affected
- 548 ccases
- Distribution
- Nationwide USA
- Location
- Columbus, OH
Frequently Asked Questions
What product 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. Recalled by American Health Packaging. Units affected: 548 ccases.
Why was this product recalled? ▼
CGMP Deviations: Potential concern with products manufactured using liquid sugar batches contaminated with microbial organisms.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on October 6, 2021. Severity: Moderate. Recall number: D-0854-2021.
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