Pfizer Initiates Voluntary Recall of Three I.V. Drugs

Pfizer (New York) is voluntarily recalling metronidazole, ciprofloxacin, and ondansetron intravenous (i.v.) products because of the presence of floating matter and non-sterility discovered by the manufacturer Claris Lifesciences (Ahmedabad, Gujarat, India). Pfizer made the announcement on June 3, following a recall initiated by Claris for all lots of the i.v. products metronidazole, ciprofloxacin, and ondansetron. These products were all manufactured on the same manufacturing line and sold under the Claris, Sagent Pharmaceuticals (Schaumburg, IL), Pfizer, and West-Ward Pharmaceuticals (Eatontown, NJ) labels.

Pfizer began distributing these Claris products to hospitals, wholesalers, and distributors in the US market this year under a licensing agreement with Claris. In 2009, Pfizer formed the agreement with Claris for the rights to 15 generic injectable drugs.

Pfizer is halting distribution of all sterile injectable products in i.v. bags licensed from Claris Lifesciences and is voluntarily recalling the products already distributed. Pfizer has distributed these products only in the US, according to Pfizer. The recall is being conducted with the knowledge of FDA. Of approximately 1.7 million i.v. bags licensed for distribution from Claris, approximately 1.3 million, or about 80%, currently remain in Pfizer’s control, according to Pfizer. Pfizer said it has received no customer reports of quality issues related to the i.v. bagged medicines from Claris Lifesciences.

All lots of the following products are affected by this recall:

• Metronidazole injection USP 500 mg/100 mL flexible i.v. plastic container (NDC 0069-2390-01)

• Ciprofloxacin in dextrose (5%) injection, USP 200 mg /100 mL flexible plastic container for i.v. infusion (NDC 0069-4395-19)

• Ciprofloxacin in dextrose (5%) injection, USP 400 mg / 200 mL flexible plastic container for i.v. infusion (NDC 0069-4396-27)

• Ondansetron in 5% Dextrose injection 32 mg / 50 mL flexible plastic container (NDC 0069-0700-12).