Class III
Terminated
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)
- Recall Initiated
- December 7, 2018
- Posted
- December 26, 2018
- Recall Number
- D-1207-2019
- Voluntary / Mandated
- Voluntary: Firm initiated
- Quantity
- 47,520 prescription packs
- Firm Location
- Cranbury, NJ, United States
Reason for Recall
Subpotent Drug: Isotretinoin content results were lower than the specification limit obtained during routing product monitoring.
Distribution
Nationwide in the USA
Lot / Code Info
Lot: 17F28AA, Exp 1/2020
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