FDA-Drug2018-12-26Class III
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)
Sun Pharmaceutical Industries, Inc.
Hazard
Subpotent Drug: Isotretinoin content results were lower than the specification limit obtained during routing product monitoring.
Sold states
Nationwide in the USA
Affected count
47,520 prescription packs
Manufactured in
270 Prospect Plains Rd, Cranbury, NJ, United States
Products
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)
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1207-2019Don't want to check this manually?
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