Agency classClass IIOur severity:Severe FDA (Drugs)·D-928-2013·Announced 2013-09-11

Teva Recalls CARBOplatin Injection Due to Sterility Assurance Failure

Teva Pharmaceuticals is recalling CARBOplatin Injection because the required reduction of endotoxin was not met during annual revalidation of the vial washer.

The agency’s classification

FDA (Drugs): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 4/5 (Severe).

The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The source text identifies the agency classification as Class II. Per the rubric, FDA Class II recalls are assigned a score of 4 (Severe), particularly when involving sterility assurance failures in injectable medications which carry significant risk of adverse health consequences.

Plain-English summary

Teva Pharmaceuticals USA, Inc. is recalling CARBOplatin Injection, 600 mg/60ml, MultiDose, Rx only. The affected product is identified by NDC 0703-3249-11 and includes 780 vials distributed nationwide. The specific lots involved are 31314458B, 31314459B, 31315794, and 31315982B, with expiration dates ranging from August 2014 to November 2014.

The recall was initiated due to a lack of assurance of sterility. Specifically, the required reduction of endotoxin was not met during the annual revalidation of the vial washer. This manufacturing process failure raises concerns about the sterility of the affected vials.

Healthcare providers and patients should discontinue use of the affected lots and contact Teva Pharmaceuticals for further instructions. The FDA has classified this recall as Class II, indicating that use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences.

The recalled product

Product: CARBOplatin Injection, 600 mg/60ml, MultiDose, Rx only, Teva Parenteral Medicines, Inc., Irvine, CA 92618 NDC 0703-3249-11
Manufacturer: Teva Pharmaceuticals USA, Inc.
Category: Drug — Injectable Medication
Hazard: sterility-failure
endotoxin
Affected units: 780

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (4)

Lot 31314458B
31314459B exp.08/14
31315794 exp. 10/14
31315982B exp.11/14

Distribution

Distributed nationwide across the United States.

Same manufacturer · Teva Pharmaceuticals USA, Inc.

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Same hazard · sterility failure