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.
Reported: August 12, 2015 Initiated: June 26, 2015 #D-1288-2015
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.
Reason for Recall
Incorrect/Undeclared Excipients: Product contains undeclared FD&C Yellow No. 5 in the capsule shell.
Details
- Recalling Firm
- Ranbaxy Inc.
- Units Affected
- 9,229 Boxes
- Distribution
- Nationwide
- Location
- Princeton, NJ
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by Ranbaxy Inc.. Units affected: 9,229 Boxes.
Why was this product recalled? ▼
Incorrect/Undeclared Excipients: Product contains undeclared FD&C Yellow No. 5 in the capsule shell.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on August 12, 2015. Severity: Moderate. Recall number: D-1288-2015.
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