FDA-Drug2015-08-12Class II

Absorica (isotretinoin) Capsules, 25 mg, Packaged in 3 x 10 Count Blister Cards/Box, Rx Only. Manufactured for: RANBAXY LABORATORIES, INC Jacksonville, FL 32257 USA. NDC: 10631-133-31.

Ranbaxy Inc.
Hazard

Incorrect/Undeclared Excipients: Product contains undeclared FD&C Yellow No. 5 in the capsule shell.

Sold states
Nationwide
Affected count
9,229 Boxes
Manufactured in
600 College Rd E Ste 2100, N/A, Princeton, NJ, United States
Products
Absorica (isotretinoin) Capsules, 25 mg, Packaged in 3 x 10 Count Blister Cards/Box, Rx Only. Manufactured for: RANBAXY LABORATORIES, INC Jacksonville, FL 32257 USA. NDC: 10631-133-31.

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1288-2015

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