Drug recall D-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.
Reason for recall
Incorrect/Undeclared Excipients: Product contains undeclared FD&C Yellow No. 5 in the capsule shell.
Lots and codes
Lot #:14H04AA, Expiry: 02/28/2017.
Recall details
- Recalling firm
- Ranbaxy Inc., Princeton, NJ
- Quantity
- 9,229 Boxes
- Distribution
- Nationwide
- Type
- Voluntary: Firm initiated
- Recall initiated
- June 26, 2015
- Terminated
- April 29, 2016
Related products
- Absorica LD – drug information
- NDC 10631-003 Absorica LD · Isotretinoin 16 mg/1 · Sun Pharmaceutical Industries, Inc.
- NDC 10631-007 Absorica LD · Isotretinoin 32 mg/1 · Sun Pharmaceutical Industries, Inc.
- NDC 10631-116 Absorica · Isotretinoin 20 mg/1 · Sun Pharmaceutical Industries, Inc.
- NDC 10631-133 Absorica · Isotretinoin 25 mg/1 · Sun Pharmaceutical Industries, Inc.
- NDC 10631-118 Absorica · Isotretinoin 40 mg/1 · Sun Pharmaceutical Industries, Inc.
- NDC 10631-117 Absorica · Isotretinoin 30 mg/1 · Sun Pharmaceutical Industries, Inc.
- NDC 10631-115 Absorica · Isotretinoin 10 mg/1 · Sun Pharmaceutical Industries, Inc.
- NDC 10631-134 Absorica · Isotretinoin 35 mg/1 · Sun Pharmaceutical Industries, Inc.
- NDC 10631-005 Absorica LD · Isotretinoin 24 mg/1 · Sun Pharmaceutical Industries, Inc.
- NDC 10631-002 Absorica LD · Isotretinoin 8 mg/1 · Sun Pharmaceutical Industries, Inc.