May 8, 2018: Notification of Stolen Octagam
Octapharma USA is working with the U.S. Food and Drug Administration (FDA), Office of Criminal Investigations (OCI), and other law enforcement officials to recover cases of select lots of prescription Octagam 10% [Immune Globulin Intravenous (Human)] liquid solution for intravenous administration. The truck containing the product was hijacked near Cornersville, Tennessee, while en route to a customer in Dothan, Alabama, on May 3, 2018, at or around 9:08 pm. The stolen truck from the carrier Despir carried partial lots of Octagam 10%.
Lot numbers of the stolen products are listed in Table 1 below. Of the two lots involved, the stolen Octagam represented 5% of the 20 mL (2G) Octagam 10% lot and 30% of the 100 mL (10G) Octagam 10% lot.
NAME | LOT # | EXPIRATION | ITEM # | DOSAGE FORM |
|---|---|---|---|---|
Octagam 10% 2G (20 mL) | M801B8541 | 1/05/20 | OF85001 | Liquid for injection |
Octagam 10% 10G (100 mL) | M811A8541 | 3/15/20 | OF85003 | Liquid for injection |
Octapharma USA recommends that consumers always inspect the product and label for signs of tampering,and evidence of particulates, cloudiness or other signs of contamination prior to use. Octagam 10% is packaged in "tamper-evident" containers, meaning that if the package has been opened, it will be evident to the consumer. In addition, consumers and retailers should report any evidence of suspected product tampering to Octapharma USA’s toll-free number 866-766-4860. This information should also be reported to FDA's MedWatch Safety Information and Adverse Event Reporting Program.
Octapharma USA advises customers to always purchase product only from licensed distributers to ensure that the product has not deviated from the authorized supply chain. Anyone who has information regarding this incident, or has received suspicious or unsolicited offers for the Octagam 10% product after the date of the theft, is encouraged to contact the U.S. Food and Drug Administration (FDA) Office of Criminal Investigations at 1-800-551-3989 or to visit the OCI Web Site.
Healthcare professionals and patients who may be in possession of these lots are encouraged to report any adverse events, side effects, or product quality problems related to the use of these lots to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:
- Complete and submit the report online
- Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178
Alternatively, healthcare professionals and patients may contact Octapharma USA toll-free at 866-766-4860.
Octapharma USA has taken quick and appropriate actions to ensure the safety of its products and will continue to work closely with law enforcement, the FDA, and distribution partners to maintain the integrity of the supply chain.