Class II · Moderate risk
Extended Phenytoin Sodium Capsules
Failed Dissolution Specifications
National Drug Code
Is NDC 65162-0212-10 recalled?
Extended Phenytoin Sodium · 100 CAPSULE in 1 BOTTLE (65162-212-10)
Yes — this exact package was recalled
2 FDA recalls name the code 65162-0212-10 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
- Phenytoin Sodium
- Strength
- PHENYTOIN SODIUM 100 mg/1
- Form
- Capsule · Oral
- Labeler
- Amneal Pharmaceuticals LLC
- Type
- Human Prescription Drug
- Product code
- 65162-0212
Recalls naming this package
Class II · Moderate risk
Extended Phenytoin Sodium Capsules
Failed Dissolution Specifications: Out-of-specification results for dissolution (above specification)
Class II · Moderate risk
Extended Phenytoin Sodium Capsules
Failed dissolution specifications; 18 month CRT
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
- 65162-0178 Metformin Hydrochloride 4
- 65162-0253 See recall 2
- 65162-0668 See recall 2
- 65162-0754 Benazepril Hydrochloride 2
- 65162-0755 Divalproex Sodium 2
- 65162-0179 Metformin Hydrochloride 1
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