Valproic Acid Oral Solution recall: CGMP Deviations
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
Why was Valproic Acid Oral Solution recalled?
CGMP Deviations: Potential concern with products manufactured using liquid sugar batches contaminated with microbial organisms.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Lot 1000082; Exp 06/30/2022
- 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
- Recalling firm
- American Health Packaging
- Quantity
- 548 ccases
- Distribution
- Nationwide USA
- Recall date
- October 6, 2021
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (drug)