Inspections, Compliance, Enforcement, and Criminal Investigations
Notification of Stolen Actavis Products
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Date Posted: November 2, 2011
On October 20, 2011, Actavis, Inc. reported to both local DEA and FDA officials that a truck, contracted by Actavis, carrying finished goods from our Elizabeth, New Jersey site to our distribution center in Kentucky was stolen. The theft was immediately reported to the police. At the present time, the subject product has not been located.
The product included in this shipment is as follows and represent full lot quantities :
Product Lot # Expiry # of Bottles
Gabapentin Tabs, USP 600 mg, 500 ct 117J11 8/31/2013 1,680
118J11 9/30/2013 1,734
206K11 9/30/2013 1,740
Alprazolam Tabs, USP 2 mg, 100 ct 001J11 8/31/2013 11,748
002J11 8/31/2013 11,700
Oxycodone HCl Tabs, USP 15 mg, 100 ct 026J11 8/31/2013 33,696
027J11 8/31/2013 34,008
Anyone who has information regarding this incident, or has received suspicious or unsolicited offers for the specified products 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 (http://www.fda.gov/OCI1). Additionally, individuals are also encouraged to immediately contact the PA police, the OH police, or the DEA with information as to how you obtained such product.
While Actavis is confident that the batches in question posed no health risk to the consumer when they left our facility, Actavis urges any individuals who may be in possession of these batches of products to discontinue their use immediately and discard the product. This recommendation is solely due to the fact that, once the theft occurred, the batches were no longer within Actavis control; therefore, we are unaware of the conditions under which the batches were stored.
Healthcare professionals and patients who may be in possession of these batches are encouraged to report any adverse events, side effects, or product quality problems related to the use of these batches to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:
- Complete and submit the report Online: www.fda.gov/MedWatch/report.htm1
- Download form2 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 the Actavis U.S.
Actavis’ top priority is the safety of its consumers and our commitment to the quality of our products. We are aggressively pursuing the retrieval of these batches through full cooperation with the police as well as FDA (OCI) and DEA authorities. We urge all consumers who are in possession of these batches to discontinue their use and follow the recommendations outlined above.
We thank you for your cooperation.