FDA-Drug2020-07-22Class II
Carbamazepine 200 mg Tablets, 100-unit dose tablets per box, Rx only, Repackaged by: RemedyRepack Inc., Indiana, PA 15701, NDC 70518-2489-00 for box; 70518-2489-01 per unit dose.
RemedyRepack Inc.
Hazard
FAILED DISSOLUTION SPECIFICATION: Low out-of-specification (OOS) dissolution results obtained during routine stability testing.
Sold states
Product was distributed to MN.
Affected count
498 tablets
Manufactured in
625 Kolter Dr Ste 4, N/A, Indiana, PA, United States
Products
Carbamazepine 200 mg Tablets, 100-unit dose tablets per box, Rx only, Repackaged by: RemedyRepack Inc., Indiana, PA 15701, NDC 70518-2489-00 for box; 70518-2489-01 per unit dose.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1387-2020Don't want to check this manually?
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