Why it was recalled
Incorrect/Undeclared Excipients: Product contains undeclared FD&C Yellow No. 5 in the capsule shell.
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.
Lot numbers, UPCs & expiration codes
Lot #:14H04AA, Expiry: 02/28/2017.
Where it was sold
Nationwide
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-1288-2015
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Jun 26, 2015
- FDA report date
- Aug 12, 2015
- Quantity
- 9,229 Boxes
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Ranbaxy Inc.
Original FDA data
Every field from FDA enforcement report D-1288-2015, exactly as published.
Show all FDA fields
- City
- Princeton
- State
- NJ
- Status
- Terminated
- Country
- United States
- Event ID
- 71865
- Address
- 600 College Rd E Ste 2100
- Code information
- Lot #:14H04AA, Expiry: 02/28/2017.
- Postal code
- 08540-6636
- Report date
- Aug 12, 2015
- Product type
- Drugs
- Recall number
- D-1288-2015
- Classification
- Class II
- Recalling firm
- Ranbaxy Inc.
- Product quantity
- 9,229 Boxes
- Termination date
- Apr 29, 2016
- Reason for recall
- Incorrect/Undeclared Excipients: Product contains undeclared FD&C Yellow No. 5 in the capsule shell.
- Voluntary / mandated
- Voluntary: Firm initiated
- 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.
- Distribution pattern
- Nationwide
- Recall initiation date
- Jun 26, 2015
- Initial firm notification
- Letter
- Center classification date
- Aug 6, 2015