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)
Reported: December 26, 2018 Initiated: December 7, 2018 #D-1207-2019
Product Description
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.
Details
- Recalling Firm
- Sun Pharmaceutical Industries, Inc.
- Units Affected
- 47,520 prescription packs
- Distribution
- Nationwide in the USA
- Location
- Cranbury, NJ
Frequently Asked Questions
What product was recalled? ▼
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). Recalled by Sun Pharmaceutical Industries, Inc.. Units affected: 47,520 prescription packs.
Why was this product recalled? ▼
Subpotent Drug: Isotretinoin content results were lower than the specification limit obtained during routing product monitoring.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on December 26, 2018. Severity: Low. Recall number: D-1207-2019.
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