FDA-Drug2025-10-08Class II

Carbamazepine Extended-Release Tablets, USP 400 mg, 30 Tablets per carton (3x10 unit dose cards), Rx Only, American Health Packaging, Columbus, OH 43217. Carton NDC 60687-594-21; (Individual Dose NDC: 60687-594-11)

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Hazard

Failed Dissolution Specifications.

Sold states
Nationwide in the USA.
Affected count
360 cartons
Manufactured in
2550 John Glenn Ave Ste A, N/A, Columbus, OH, United States
Products
Carbamazepine Extended-Release Tablets, USP 400 mg, 30 Tablets per carton (3x10 unit dose cards), Rx Only, American Health Packaging, Columbus, OH 43217. Carton NDC 60687-594-21; (Individual Dose NDC: 60687-594-11)

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0675-2025

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