FDAFDA · Food and drugs·Recall number D-1207-2019
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)
Published December 26, 2018 · Recall initiated: December 7, 2018
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Subpotent Drug: Isotretinoin content results were lower than the specification limit obtained during routing product monitoring.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Sun Pharmaceutical Industries, Inc.
- Distributor
- Nationwide in the USA
- Lot
- Lot: 17F28AA, Exp 1/2020
- Risk classification
- Class III
- Area (FDA)
- drug
- Country
- United States
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