Class II · Moderate risk
Carbamazepine Tablets
CGMP Deviations; black spots found on tablets from burnt excipient during manufacturing
National Drug Code
Is NDC 51672-4005-03 recalled?
Carbamazepine · 1000 TABLET in 1 BOTTLE (51672-4005-3)
Yes — this exact package was recalled
2 FDA recalls name the code 51672-4005-03 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.
1 of these recalls is still ongoing.
- Active ingredient
- Carbamazepine
- Strength
- CARBAMAZEPINE 200 mg/1
- Form
- Tablet · Oral
- Labeler
- Sun Pharmaceutical Industries, Inc.
- Type
- Human Prescription Drug
- Product code
- 51672-4005
Recalls naming this package
Class III · Low risk
Carbamazepine Tablets USP
Marketed without an Approved NDA/ANDA: One lot was on hold-pending release status when it was erroneously made available for sale in the inventory control system. An alternate manufacturing site for the Carbamazepine API final intermediate was pending approval.
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
- 51672-1386 Fluocinonide 3
- 51672-1351 Ciclopirox 2
- 51672-1385 Ibuprofen 2
- 51672-2130 Ibuprofen 2
- 51672-3007 Hydrocortisone and Acetic Acid 2
- 51672-4027 Warfarin Sodium 2
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