Class II · Moderate risk
Divalproex Sodium Extended-Release Tablets
cGMP deviations: Product was exposed above 50% relative humidity levels during packaging operations.
National Drug Code
Is NDC 55111-0533-01 recalled?
Divalproex Sodium · 100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (55111-533-01)
Yes — this exact package was recalled
3 FDA recalls name the code 55111-0533-01 directly. A recall still applies to particular lot numbers — compare the lot on your package with the FDA notice below, and talk to your pharmacist before stopping a prescribed medication.
- Active ingredient
- Divalproex Sodium
- Strength
- DIVALPROEX SODIUM 250 mg/1
- Form
- Tablet, Film Coated, Extended Release · Oral
- Labeler
- Dr. Reddy's Laboratories Ltd
- Type
- Human Prescription Drug
- Product code
- 55111-0533
Recalls naming this package
Class II · Moderate risk
Divalproex Sodium Extended-release Tablets
Failed Dissolution Specifications: Out of specification results observed for high dissolution.
Class II · Moderate risk
Divalproex Sodium Extended-Release Tablets
Failed Dissolution Specifications; exceeded specification at the 9 hour time point
Where to find this code. The NDC is printed on the pharmacy label and on the manufacturer's carton, usually as three groups of digits after “NDC”. The last group is the package size — two bottles of the same medicine can differ only in that group, and a recall may cover one but not the other.
Other recalled products from this labeler
- 55111-0121 Atorvastatin Calcium 4
- 55111-0123 Atorvastatin Calcium 4
- 55111-0180 Tizanidine 4
- 55111-0136 Zenatane 3
- 55111-0179 Tizanidine 3
- 55111-0320 Glimepiride 3
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