Drug product
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.
D-1288-2015
Product summary
- Firm
- Ranbaxy Inc.
- Event
- Event 71865
- Status
- Terminated
- Classification
- Class II
- Quantity
- 9,229 Boxes
- Official record key
drug-enforcement:D-1288-2015
Official wording
Reason: Incorrect/Undeclared Excipients: Product contains undeclared FD&C Yellow No. 5 in the capsule shell.
Code information: Lot #:14H04AA, Expiry: 02/28/2017.
Distribution pattern: Nationwide
Derived failure modes
-
Unknown
Incorrect/Undeclared Excipients: Product contains undeclared FD&C Yellow No. 5 in the capsule shell.