Drug Product Recall Due to Possible Penicillin Contamination
Drug Product Recall Due to Possible Penicillin Contamination
June 3, 2011 — A voluntary recall of multiple repackaged products is under way because of a potential cross-contamination of nonpenicillin drug products with penicillin products, according to a safety alert from the US Food and Drug Administration (FDA).
Aidapak Services and the FDA notified healthcare professionals and hospital pharmacies of the recall in an announcement this week through the FDA's MedWatch Safety Information and Adverse Event Reporting Program.
When contacted by Medscape Medical News, Aidapak Services declined to provide an estimate of the number of affected drug products. A spokesperson for the company stated that they did not need to respond to any media questions.
According to the alert, there is the "potential for serious anaphylactic reaction in patients with known hypersensitivity to β-lactam or penicillin products that could result from using these recalled products."
The FDA recommends that hospitals, emergency departments, clinics, and other healthcare facilities "stop distributing these products immediately and quarantine the products and then contact Aidapak Services for return instructions."
In a company press release, Aidapak Services stated that it has instituted a "complete cleaning and decontamination of the facilities followed by testing by 2 separate laboratories to ensure the absence of any penicillin or nonpenicillin β-lactam contaminates."
Adverse events or quality concerns related to these products should be reported to MedWatch by telephone at 1-800-332-1088, by fax at 1-800-332-1078, online at https://www.accessdata.fda.gov/scripts/medwatch/medwatch-online.htm, or by mail to MedWatch, 5600 Fishers Lane, Rockville, MD 20857.
The recall list of the affected lot numbers, available on the Aidapak Web site, is more than 300 pages long, indicating that the recall is wide reaching. All products affected by this recall are stamped with Aidapak's packaging stamp.
June 3, 2011 — A voluntary recall of multiple repackaged products is under way because of a potential cross-contamination of nonpenicillin drug products with penicillin products, according to a safety alert from the US Food and Drug Administration (FDA).
Aidapak Services and the FDA notified healthcare professionals and hospital pharmacies of the recall in an announcement this week through the FDA's MedWatch Safety Information and Adverse Event Reporting Program.
When contacted by Medscape Medical News, Aidapak Services declined to provide an estimate of the number of affected drug products. A spokesperson for the company stated that they did not need to respond to any media questions.
According to the alert, there is the "potential for serious anaphylactic reaction in patients with known hypersensitivity to β-lactam or penicillin products that could result from using these recalled products."
The FDA recommends that hospitals, emergency departments, clinics, and other healthcare facilities "stop distributing these products immediately and quarantine the products and then contact Aidapak Services for return instructions."
In a company press release, Aidapak Services stated that it has instituted a "complete cleaning and decontamination of the facilities followed by testing by 2 separate laboratories to ensure the absence of any penicillin or nonpenicillin β-lactam contaminates."
Adverse events or quality concerns related to these products should be reported to MedWatch by telephone at 1-800-332-1088, by fax at 1-800-332-1078, online at https://www.accessdata.fda.gov/scripts/medwatch/medwatch-online.htm, or by mail to MedWatch, 5600 Fishers Lane, Rockville, MD 20857.
The recall list of the affected lot numbers, available on the Aidapak Web site, is more than 300 pages long, indicating that the recall is wide reaching. All products affected by this recall are stamped with Aidapak's packaging stamp.
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