FDA Drug Class III — Least Serious

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)

Hazard

Subpotent Drug: Isotretinoin content results were lower than the specification limit obtained during routing product monitoring.

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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 Pharmaceutica
Brand
Sun Pharmaceutical Industries, Inc.
UPC
Lot: 17F28AA, Exp 1/2020

Units Affected

47,520 prescription packs

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