Recalls / Class II
Class IID-1288-2015
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.
- Brand name
- Absorica Ld
- Generic name
- Isotretinoin
- Active ingredient
- Isotretinoin
- Route
- Oral
- NDCs
- 10631-002, 10631-115, 10631-116, 10631-117, 10631-118, 10631-133, 10631-134, 10631-003, 10631-004, 10631-005 +2 more
- FDA application
- NDA211913
- Affected lot / code info
- Lot #:14H04AA, Expiry: 02/28/2017.
Why it was recalled
Incorrect/Undeclared Excipients: Product contains undeclared FD&C Yellow No. 5 in the capsule shell.
Recalling firm
- Firm
- Ranbaxy Inc.
- Manufacturer
- Sun Pharmaceutical Industries, Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 600 College Rd E Ste 2100, N/A, Princeton, New Jersey 08540-6636
Distribution
- Quantity
- 9,229 Boxes
- Distribution pattern
- Nationwide
Timeline
- Recall initiated
- 2015-06-26
- FDA classified
- 2015-08-06
- Posted by FDA
- 2015-08-12
- Terminated
- 2016-04-29
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-1288-2015. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.