FDA 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.

Distribution

Nationwide in the USA

Key facts

Status

Terminated

Initiation date

2018-12-07

Report date

2018-12-26

Termination date

2019-06-14

Voluntary/Mandated

Voluntary: Firm initiated

Location

Cranbury, NJ, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1207-2019