June 2015 FDA Recall Absorica Ld by Ranbaxy Inc.
D-1288-2015 - Incorrect/Undeclared Excipients
This Class II drug recall was voluntarily initiated by Ranbaxy Inc. on June 26, 2015 for the product Absorica Ld. The FDA reported the reason for recall as incorrect/undeclared excipients. The product was distributed Nationwide and the recall is currently terminated.
Recall Number: D-1288-2015
Incorrect/Undeclared Excipients: Product contains undeclared FD&C Yellow No. 5 in the capsule shell.
06-26-2015
08-12-2015
9,229 Boxes
Recall Profile & Regulatory Data
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
Ranbaxy Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Nationwide
04-29-2016
Product Description About Product Description
Full technical description of the product.
Full technical description of the 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.
Batch or Lot Expiration Information
Lot# :14H04AA, Expiry: 02/28/2017.
