3 lots Ipratropium & 4 lots Albuterol inhalation solutions, stolen, mishandled

[notyard]

FDA press release--first a load of albuterol stolen from Texas, now a load of ipratropium and albuterol stolen from Florida:

Stolen Ipratropium Bromide and Albuterol Inhalation Solutions


Dey Issues Advisory

NAPA, Calif., Sept. 11 /PRNewswire-FirstCall/ -- Dey L.P., a subsidiary of Mylan Inc. (Nasdaq: MYL), today issued an advisory regarding the theft of two different types of its respiratory medications, Ipratropium Bromide Inhalation Solution, 0.02%, and Albuterol Sulfate Inhalation Solution, 0.083%, unit-dose vials. The lots were on a tractor-trailer that was stolen in the state of Florida.
The NDC numbers for the Ipratropium product are 49502-685-31 (lot number F09089) and 49502-685-62 (lot numbers C09119 and C09120). All packages contain 2.5 ml vials and display the brand name "DEY."
The NDC numbers for the Albuterol product are 49502-697-29 (lot number 9G04) and 49502-697-61 (lot numbers 9FD8, 9FD9 and 9FE1). All packages contain 3.0 ml vials and display the brand name "DEY."
In the weeks prior to the truck theft, some portion of each lot had been sold by Dey to its customers and successfully entered the legitimate pharmaceutical supply chain. Because the stolen product may have been stored or handled improperly, Dey is requesting that any and all product with the affected lot numbers be isolated and not be dispensed, sold or used. Dey has alerted its distributors and customers.
Anyone who has information about this incident, has received suspicious or unsolicited offers for the products in question or received product from these lots is encouraged to contact the U.S. Food and Drug Administration (FDA) Office of Criminal Investigations at 1.800.551.3989. Patient or customer inquiries for the company should be directed to Dey Customer Service at 1.800.527.4278.
Dey discourages patients from purchasing any medication sold outside of legitimate channels.

[notyard]

FDA reissuing and stepping up the warning:

FDA NEWS RELEASE

For Immediate Release: Sept. 17, 2009
Media Inquiries: Christopher Kelly, Christopher.Kelly@fda.hhs.gov, 301-796-4676
Consumer Inquiries: 888-INFO-FDA
FDA Warns Consumers Not to Use Stolen Albuterol Sulfate Inhalation Solution and Ipratropium Bromide Inhalation Solution

The U.S. Food and Drug Administration today advised consumers not to use certain respiratory medications purchased after Sept. 8, 2009 and manufactured by Dey L.P., a subsidiary of Mylan Inc., because the medications might have been part of a shipment being transported on a tractor-trailer stolen in Tampa, Fla., on Sept. 8, 2009.
The respiratory medications, Ipratropium Bromide Inhalation Solution, 0.02%, and Albuterol Sulfate Inhalation Solution, 0.083%, unit-dose vials, have not been recovered and may be dangerous to use because the drugs may not have been stored and handled properly.
Dey issued an advisory on Sept. 11, 2009 regarding the theft. Although the FDA is not aware of any reports of adverse events, the agency is advising patients who use these respiratory medications to check to see if products received or purchased after Sept. 8, 2009 are from one of the following lots:
Albuterol Sulfate Inhalation Solution (892,000 doses; all lots contain 3.0 ml vials and display the brand name “Dey”)

• Lot number 9G04, NDC # 49502-697-29
• Lot number 9FD8, NDC # 49502-697-61
• Lot number 9FD9, NDC # 49502-697-61
• Lot number 9FE1, NDC # 49502-697-61

Ipratropium Bromide Inhalation Solution (432,000 doses; all lots contain 2.5 ml vials and display the brand name “Dey”)

• Lot number F09089, NDC # 49502-685-31
• Lot number C09119, NDC # 49502-685-62
• Lot number C09120, NDC # 49502-685-62

Do not use Albuterol Sulfate Inhalation Solution or Ipratropium Bromide Inhalation Solution if it is from one of these lots and was purchased or received after Sept. 8, 2009. Replace it with the same product from another lot.
Notify your health care professional of any adverse effects you may have experienced as a result of taking these medications.
Bring products from these lots back to the pharmacy where you received the medicine to exchange for products from a different lot or call Dey customer service at 800-527-4278. Contact your health care professional if you must switch to another product for any reason for possible dose adjustments.
The FDA is asking for the public's help in reporting any information regarding the stolen Dey products to the FDA's Office of Criminal Investigations (OCI) by calling 800-551-3989 or by visiting the OCI Web site (http://www.fda.gov/OCI).