D-1207-2019 Class III Terminated
FDA drug recall D-1207-2019 was initiated by Sun Pharmaceutical Industries, Inc. on Dec 7, 2018 and is designated Class III. Reason for recall: Subpotent Drug: Isotretinoin content results were lower than the specification limit obtained during routing product monitoring. The recall status is terminated (terminated Jun 14, 2019). Affected quantity: 47,520 prescription packs.
Recall Details
- Product Type
- Drugs
- Report Date
- Dec 26, 2018
- Initiation Date
- Dec 7, 2018
- Termination Date
- Jun 14, 2019
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 47,520 prescription packs
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.
Distribution Pattern
Nationwide in the USA
Code Information
Lot: 17F28AA, Exp 1/2020
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-1207-2019
- openFDA file date
- Oct 21, 2026
- Loaded by RegDataLab
- Oct 23, 2026