Absorica (Isotretinoin) Capsules 30 mg USP, 30 capsules (3x10 Prescription Packs) Rx only, Manuf...
FDA Recall #D-1207-2019 — Class III — December 7, 2018
Product Description
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)
Reason for Recall
Subpotent Drug: Isotretinoin content results were lower than the specification limit obtained during routing product monitoring.
Recalling Firm
Sun Pharmaceutical Industries, Inc. — Cranbury, NJ
Classification
Class III — Not likely to cause adverse health consequences.
Product Type
Drugs
Product Quantity
47,520 prescription packs
Distribution
Nationwide in the USA
Code Information
Lot: 17F28AA, Exp 1/2020
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated