December 2018 FDA Recall Absorica Ld by Sun Pharmaceutical Industries, Inc.
D-1207-2019 - Subpotent Drug
This Class III drug recall was voluntarily initiated by Sun Pharmaceutical Industries, Inc. on December 7, 2018 for the product Absorica Ld. The FDA reported the reason for recall as subpotent drug. The product was distributed Nationwide and the recall is currently terminated.
Recall Number: D-1207-2019
Subpotent Drug: Isotretinoin content results were lower than the specification limit obtained during routing product monitoring.
12-07-2018
12-26-2018
47,520 prescription packs
Recall Profile & Regulatory Data
Class III - is a situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequences.
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
Sun Pharmaceutical Industries, Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Nationwide in the USA
06-14-2019
Product Description About Product Description
Full technical description of the product.
Full technical description of the 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)
Batch or Lot Expiration Information
Lot# Lot: 17F28AA, Exp 1/2020
