Absorica (Isotretinoin) Capsules 30 mg USP…

Date

Dec. 26, 2018

Risk class

Class III (FDA's definition, 21 CFR 7.3(m): a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences)

Status

Terminated

Filed by

Sun Pharmaceutical Industries, Inc.

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)

Reason

Subpotent Drug: Isotretinoin content results were lower than the specification limit obtained during routing product monitoring.

Distribution pattern

Nationwide in the USA

Quantity

47,520 prescription packs

Codes and lots

Lot: 17F28AA, Exp 1/2020

Recall started

Dec. 7, 2018

Recall number

D-1207-2019

What should I do? Medicine recall: what to do

Source: FDA · Drug enforcement report, recall number D-1207-2019. The agency record governs; check it and the company before acting.