Absorica Ld Capsule
FDA Recall NDC 10631-005
FDA Enforcement Report: View Recall Date, Reasons, and Safety Status
Active & Historical Enforcement Reports
The FDA has identified 2 recorded enforcement report(s) associated with Absorica Ld (NDC 10631-005). A significant event, classified as Class III, was initiated on Dec 07, 2018 by Sun Pharmaceutical Industries, Inc.. The reported reason for this action was: "Subpotent Drug: Isotretinoin content results were lower than the specification limit obtained during routing product monitoring."
This specific recall has a current status of TERMINATED, indicating that the FDA considers the recall process finished or the product successfully recovered.
This specific recall has a current status of TERMINATED, indicating that the FDA considers the recall process finished or the product successfully recovered.
Reported Recall Events
Class III Terminated
Subpotent Drug: Isotretinoin content results were lower than the specification limit obtained during routing product monitoring.
Dec 07, 2018
Dec 26, 2018
47,520 prescription packs
Recall Profile & Regulatory Data
Event ID
81765
Classification
Class III
Enforcement Status
Terminated
Recalling Firm
Sun Pharmaceutical Industries, Inc.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide in the USA
Termination Date
Jun 14, 2019
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)
Batch or Lot Expiration Information
Lot# Lot: 17F28AA, Exp 1/2020
Affected Packages Involved in this Recall
10631-115-69Product
10631-115-31Product
10631-116-69Product
10631-116-31Product
10631-117-69Product
10631-117-31Product
10631-118-69Product
10631-118-31Product
10631-133-69Product
10631-133-31Product
10631-134-69Product
10631-134-31Product
10631-002-31Product
10631-003-31Product
10631-004-31Product
10631-005-31Product
10631-006-31Product
10631-007-31Product
3106311173Product
Class II Terminated
Incorrect/Undeclared Excipients: Product contains undeclared FD&C Yellow No. 5 in the capsule shell.
Jun 26, 2015
Aug 12, 2015
9,229 Boxes
Recall Profile & Regulatory Data
Event ID
71865
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
Ranbaxy Inc.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide
Termination Date
Apr 29, 2016
Product Description
Absorica (isotretinoin) Capsules, 25 mg, Packaged in 3 x 10 Count Blister Cards/Box, Rx Only. Manufactured for: RANBAXY LABORATORIES, INC Jacksonville, FL 32257 USA. NDC: 10631-133-31.
Batch or Lot Expiration Information
Lot# :14H04AA, Expiry: 02/28/2017.
Affected Packages Involved in this Recall
10631-115-69Product
10631-115-31Product
10631-116-69Product
10631-116-31Product
10631-117-69Product
10631-117-31Product
10631-118-69Product
10631-118-31Product
10631-133-69Product
10631-133-31Product
10631-134-69Product
10631-134-31Product
10631-002-31Product
10631-003-31Product
10631-004-31Product
10631-005-31Product
10631-006-31Product
10631-007-31Product
About FDA Recall Enforcement Reports
FDA recall data documents classified recall actions associated with a product. Most recalls are limited to specific lots, batches, or package configurations rather than every unit of a drug.
If a recall is listed for an NDC, review the affected lot information and package details carefully. Patients and healthcare professionals should confirm whether a specific product in hand matches the lot or package information before assuming it is affected.
