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  5. August 7, 2017: Notification of Stolen Sterile Prescription Injectable Products
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August 7, 2017: Notification of Stolen Sterile Prescription Injectable Products

AuroMedics Pharma LLC (AuroMedics) is working with the U.S. Food and Drug Administration (FDA), and other law enforcement officials to recover three lots of sterile prescription injectable products. The trailer containing the products was stolen while en route to the Aurobindo Pharma Distribution Center in Dayton, NJ during July 27-28, 2017.  The trailer was parked at a security yard in Elizabeth, NJ at the time of the theft.  The stolen trailer contained two different AuroMedics products. The theft was immediately reported to the police. At the present time, the subject product has not been located.

The impacted lots are listed in the table below.

Product Name

Lot Number

Expiry

Market Units (Unit of Sale)

Total

Levofloxacin in 5% Dextrose Injection 750mg/150mL Bag

CLF170020A

May 2019

220 x 24

5280 bags

CLF170021A

May 2019

477 x 24

11448 bags

Bupivicaine HCl Injection USP 0.5% 30mL Vial

CBU170091

April 2019

1512 x 25

37800 vials

 

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’s (FDA) Office of Criminal Investigations (OCI) at 1-800-551-3989 or to visit the OCI Web Site (http://www.fda.gov/OCI).  Additionally, individuals are also encouraged to immediately contact their local police with information as to how the above listed product was obtained.

AuroMedics advises physicians, retailers, and consumers to check all products for signs of tampering or damage prior to use.  Do not use the product if the packaging appears to have been disturbed in any way.  It is always advisable to purchase product only from trusted and reliable sources and to be aware that an unusually low price may be an indication that the product may have been stolen.  While AuroMedics is confident that the batches in question posed no health risk to the patient when they left our facility, AuroMedics 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 AuroMedics 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.htm

·       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 the AuroMedics Pharmacovigilance department toll-free at 1-888-238-7880 – prompt #2.

We thank you for your cooperation.