Sun Pharmaceutical Industries, Inc. recalls Absorica (Isotretinoin) Capsules 30 mg USP, 30 capsules (3x10 Prescription Packs) Rx only, Manufactured by: Galephar P
Recalled December 26, 2018 · FDA recall D-1207-2019 · Sun Pharmaceutical Industries
Hazard
Subpotent Drug: Isotretinoin content results were lower than the specification limit obtained during routing product monitoring. · FDA Class III
Units
47,520 prescription packs
Sold at
Nationwide in the USA
Description
Subpotent Drug: Isotretinoin content results were lower than the specification limit obtained during routing product monitoring.
Product
Absorica (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)
Manufacturer(s)
Sun Pharmaceutical Industries, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →