Drug recall D-1207-2019
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)
Reason for recall
Subpotent Drug: Isotretinoin content results were lower than the specification limit obtained during routing product monitoring.
Lots and codes
Lot: 17F28AA, Exp 1/2020
Recall details
- Recalling firm
- Sun Pharmaceutical Industries, Inc., Cranbury, NJ
- Quantity
- 47,520 prescription packs
- Distribution
- Nationwide in the USA
- Type
- Voluntary: Firm initiated
- Recall initiated
- December 7, 2018
- Terminated
- June 14, 2019
Related products
- Absorica LD – drug information
- NDC 10631-003 Absorica LD · Isotretinoin 16 mg/1 · Sun Pharmaceutical Industries, Inc.
- NDC 10631-007 Absorica LD · Isotretinoin 32 mg/1 · Sun Pharmaceutical Industries, Inc.
- NDC 10631-116 Absorica · Isotretinoin 20 mg/1 · Sun Pharmaceutical Industries, Inc.
- NDC 10631-133 Absorica · Isotretinoin 25 mg/1 · Sun Pharmaceutical Industries, Inc.
- NDC 10631-118 Absorica · Isotretinoin 40 mg/1 · Sun Pharmaceutical Industries, Inc.
- NDC 10631-117 Absorica · Isotretinoin 30 mg/1 · Sun Pharmaceutical Industries, Inc.
- NDC 10631-115 Absorica · Isotretinoin 10 mg/1 · Sun Pharmaceutical Industries, Inc.
- NDC 10631-134 Absorica · Isotretinoin 35 mg/1 · Sun Pharmaceutical Industries, Inc.
- NDC 10631-005 Absorica LD · Isotretinoin 24 mg/1 · Sun Pharmaceutical Industries, Inc.
- NDC 10631-002 Absorica LD · Isotretinoin 8 mg/1 · Sun Pharmaceutical Industries, Inc.