48,000 Grams of Octagam Stolen: Beware of Unusual Sales Offers

FFF was informed today that approximately 48,000 grams of Octapharma’s Octagam® were stolen from a DHL facility in Chicago.

The stolen Octagam was 10-gram vials (NDC# 67467 843-04) with the following lot numbers:

1. Lot# 5160308431 (Quantity 2,336 vials)
2. Lot# 5160318431 (Quantity 2,472 vials)

There is a potential safety issue with this product: There is no guarantee that it will be stored properly.

The manufacturer recommends the following storage conditions: “Octagam may be stored for 24 months at +2°C to +8°C (36°F to 46°F) or may be stored at temperatures not to exceed +25°C (77°F) for up to 18 months from the date of manufacture.”

If you are offered this product, please call the FDA Office of Criminal Investigations in Maryland:

Kathleen Martin-Weis, Special Agent in Charge, Investigative Operations Division, 301-294-4030.

Counterfeiters will commonly obtain real product, dilute it, copy the packaging and/or otherwise tamper with the product, and then resell it into the secondary distribution channel. Consequently, if, over the next few months, you receive product that appears at all unusual or with packaging that appears damaged, altered or otherwise tampered with, please call the FDA Office of Criminal Investigations in Maryland:

Kathleen Martin-Weis, Special Agent in Charge, Investigative Operations Division, 301-294-4030.

For guidance on how to identify tampered and counterfeit product, please visit www.fffenterprises.com, and click on “Pharmaceutical Counterfeiting: Preventing the Perfect Crime.”