Recall Enforment Report D-1207-2019

Drug Recall Enforcement Report Class III voluntary initiated by Sun Pharmaceutical Industries, Inc., originally initiated on 12-07-2018 for 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) The product was recalled due to subpotent drug: isotretinoin content results were lower than the specification limit obtained during routing product monitoring.. The product was distributed nationwide and the recall is currently terminated.

Field Name Field Value
Event ID 81765 What is the Event ID?
A numerical designation assigned by FDA to a specific recall event (used for tracking purposes).
Recall Number D-1207-2019 What is the Recall Number?
An alphanumeric designation assigned by FDA to a specific, classified recalled product (used for tracking purposes).
Recall Classification Class III - is a situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequences. What is the Recall Classification?
Numerical designation (I, II, or III) that is assigned by FDA to a particular product recall that indicates the relative degree of health hazard. For recalls pending classification, the entry will display as "Not Yet Classified".
Distribution Pattern Nationwide in the USA What is the Distribution Pattern?
General area of initial distribution such as states, countries, or territories. Note that subsequent distribution by the consignees to other parties may not be included.
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. What is the Reason for Recall?
Information describing how the product is defective.
Product Quantity 47,520 prescription packs Product Quantity
The amount of product subject to recall.
Voluntary Mandated Voluntary: Firm initiated Voluntary / Mandated
Designates that a recall was initiated voluntarily by a firm on its own volition or after being requested to recall by FDA. “Mandatory” designates that a recall was initiated under a mandatory (statutory) recall authority, a court order, or FDA order.
Report Date 12-26-2018
Recall Initiation Date 12-07-2018 What is the Recall Initiation Date?
The date that the firm first began notifying the public or their consignees of the recall.
Termination Date 06-14-2019 What is the Date Terminated?
The date that FDA terminated the recall.
Initial Firm Notification Letter Initial Firm Notification of Consignee or Public
The method(s) by which the firm initially notified the public or their consignees of a recall.
Product Type Drugs
Recalling Firm Sun Pharmaceutical Industries, Inc.
Code Info Lot: 17F28AA, Exp 1/2020 Code Information
A list of all lot and/or serial numbers, product numbers, expiration dates, sell or use by dates, etc., which appear on the product or its labeling.
Recalled NDC Packages 10631-115-69; 10631-115-31; 10631-116-69; 10631-116-31; 10631-117-69; 10631-117-31; 10631-118-69; 10631-118-31; 10631-133-69; 10631-133-31; 10631-134-69; 10631-134-31; 10631-002-31; 10631-003-31; 10631-004-31; 10631-005-31; 10631-006-31; 10631-007-31; 3106311173
Status Terminated - A recall where FDA has determined that all reasonable efforts have been made to remove or correct the violative product in accordance with the recall strategy, and proper disposition has been made according to the degree of hazard.

Recalled Products

NDC Proprietary Name Non-Proprietary Name Dosage Form Route Name Company Name Product Type
10631-002Absorica Ld IsotretinoinCapsuleOralSun Pharmaceutical Industries, Inc.Human Prescription Drug
10631-003Absorica Ld IsotretinoinCapsuleOralSun Pharmaceutical Industries, Inc.Human Prescription Drug
10631-005Absorica Ld IsotretinoinCapsuleOralSun Pharmaceutical Industries, Inc.Human Prescription Drug
10631-007Absorica Ld IsotretinoinCapsuleOralSun Pharmaceutical Industries, Inc.Human Prescription Drug
10631-115Absorica IsotretinoinCapsuleOralSun Pharmaceutical Industries, Inc.Human Prescription Drug
10631-116Absorica IsotretinoinCapsuleOralSun Pharmaceutical Industries, Inc.Human Prescription Drug
10631-117Absorica IsotretinoinCapsuleOralSun Pharmaceutical Industries, Inc.Human Prescription Drug
10631-118Absorica IsotretinoinCapsuleOralSun Pharmaceutical Industries, Inc.Human Prescription Drug
10631-133Absorica IsotretinoinCapsuleOralSun Pharmaceutical Industries, Inc.Human Prescription Drug
10631-134Absorica IsotretinoinCapsuleOralSun Pharmaceutical Industries, Inc.Human Prescription Drug