D-1288-2015 Class II Terminated
FDA drug recall D-1288-2015 was initiated by Ranbaxy Inc. on June 26, 2015 and is designated Class II. Reason for recall: Incorrect/Undeclared Excipients: Product contains undeclared FD&C Yellow No. 5 in the capsule shell. The recall status is terminated (terminated April 29, 2016). Affected quantity: 9,229 Boxes.
Recall Details
- Product Type
- Drugs
- Report Date
- August 12, 2015
- Initiation Date
- June 26, 2015
- Termination Date
- April 29, 2016
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 9,229 Boxes
Product Description
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.
Reason for Recall
Incorrect/Undeclared Excipients: Product contains undeclared FD&C Yellow No. 5 in the capsule shell.
Distribution Pattern
Nationwide
Code Information
Lot #:14H04AA, Expiry: 02/28/2017.