FDAFDA · Food and drugs·Recall number D-1288-2015
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.
Published August 12, 2015 · Recall initiated: June 26, 2015
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Incorrect/Undeclared Excipients: Product contains undeclared FD&C Yellow No. 5 in the capsule shell.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Ranbaxy Inc.
- Distributor
- Nationwide
- Lot
- Lot #:14H04AA, Expiry: 02/28/2017.
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
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