Drug 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)
D-1207-2019
Product summary
- Event
- Event 81765
- Status
- Terminated
- Classification
- Class III
- Quantity
- 47,520 prescription packs
- Official record key
drug-enforcement:D-1207-2019
Official wording
Reason: Subpotent Drug: Isotretinoin content results were lower than the specification limit obtained during routing product monitoring.
Code information: Lot: 17F28AA, Exp 1/2020
Distribution pattern: Nationwide in the USA
Derived failure modes
-
Potency or specification failure
Subpotent