Patients, healthcare providers urged to discard, report involved product

On October 20, 2011, Actavis, Inc. reported to both U.S. Drug Enforcement Administration and U.S. Food and Drug Administration officials that a truck, contracted by Actavis, carrying finished goods from the comapany’s Elizabeth New Jersey site to its 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:

Product	Lot No.	Expiry
Gabapentin Tabs, USP 600 mg, 500 ct	117J11 118J11 206K11	8/31/2013 9/30/2013 9/30/2013
Alprazolam Tabs, USP 2 mg, 100 ct	001J11 002J11	8/31/2013 8/31/2013
Oxycodone HCl Tabs, USP 15 mg, 100 ct	026J11 027J11	8/31/2013 8/31/2013

Any individuals who may be in possession of products from any of these batches are encouraged to immediately contact the Pennsylvania state police, the Ohio state police, the DEA or the FDA Office of Criminal Investigation at 1-800-551-3989 with information as to how the product was obtained.

While Actavis is confident that the batches in question posed no health risk to the consumer when they left the facility, Actavis urges any individuals who may be in possession of these batches of products to discontinue 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, the company is 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.htm

Download Form 3500 or call 1-800-332-1088 to request a Voluntary 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. Medical Affairs department toll-free at 1-800-432-8534.

Actavis’ top priority is the safety of its consumers and its commitment to the quality of our products. The company is aggressively pursuing the retrieval of these batches through full cooperation with the police as well as FDA (OCI) and DEA authorities. Consumers who are in possession of these batches are urged to discontinue their use and follow the recommendations outlined above.

Thank you for your cooperation.