Recall Enforment Report D-1207-2019
Drug Recall Enforcement Report Class III voluntary initiated by Sun Pharmaceutical Industries, Inc., originally initiated on 12-07-2018 for the 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) The product was recalled due to subpotent drug: isotretinoin content results were lower than the specification limit obtained during routing product monitoring.. The product was distributed nationwide and the recall is currently terminated.
Recalled Products
NDC | Proprietary Name | Non-Proprietary Name | Dosage Form | Route Name | Company Name | Product Type |
---|---|---|---|---|---|---|
10631-002 | Absorica Ld | Isotretinoin | Capsule | Oral | Sun Pharmaceutical Industries, Inc. | Human Prescription Drug |
10631-003 | Absorica Ld | Isotretinoin | Capsule | Oral | Sun Pharmaceutical Industries, Inc. | Human Prescription Drug |
10631-005 | Absorica Ld | Isotretinoin | Capsule | Oral | Sun Pharmaceutical Industries, Inc. | Human Prescription Drug |
10631-007 | Absorica Ld | Isotretinoin | Capsule | Oral | Sun Pharmaceutical Industries, Inc. | Human Prescription Drug |
10631-115 | Absorica | Isotretinoin | Capsule | Oral | Sun Pharmaceutical Industries, Inc. | Human Prescription Drug |
10631-116 | Absorica | Isotretinoin | Capsule | Oral | Sun Pharmaceutical Industries, Inc. | Human Prescription Drug |
10631-117 | Absorica | Isotretinoin | Capsule | Oral | Sun Pharmaceutical Industries, Inc. | Human Prescription Drug |
10631-118 | Absorica | Isotretinoin | Capsule | Oral | Sun Pharmaceutical Industries, Inc. | Human Prescription Drug |
10631-133 | Absorica | Isotretinoin | Capsule | Oral | Sun Pharmaceutical Industries, Inc. | Human Prescription Drug |
10631-134 | Absorica | Isotretinoin | Capsule | Oral | Sun Pharmaceutical Industries, Inc. | Human Prescription Drug |