FDA Recalls NDC 10631-117 Absorica
Isotretinoin Capsule Oral

FDA Recalls Enforcement Reports

The last Recall Enforcement Report for Absorica with NDC 10631-117 was initiated on 12-07-2018 as a Class III recall due to subpotent drug: isotretinoin content results were lower than the specification limit obtained during routing product monitoring. The latest recall number for this product is D-1207-2019 and the recall is currently terminated as of 06-14-2019 .

Recall Number Initiation Date Report Date Recall Classification Product Quantity Product Description Status
D-1207-201912-07-201812-26-2018Class III47,520 prescription packsAbsorica (Isotretinoin) Capsules 30 mg USP, 30 capsules (3x10 Prescription Packs) Rx only, Manufactured by: Galephar Pharmaceutical Research Inc. Humacao, PR 00792, Distributed by: Sun Pharmaceutical Industries Inc. Cranbury, NJ 08512, UPC 310631117313, NDC 10631-117-31 (carton) NDC10631-117-69 (prescription pack)Terminated
D-1288-201506-26-201508-12-2015Class II9,229 BoxesAbsorica (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.Terminated

What is the Enforcement Report?

All drug recalls are monitored by the Food and Drug Administration (FDA) and are included in the Enforcement Report once they are properly classified. The FDA will determine if a firm's removal or correction actions of a marked product meet the requirements to be considered a "recall". The FDA will also determine the public hazard assessment and a recall classification will be published in the Enforcement Report.