Stop using now Drug recall · FDA · Published August 13, 2013

Teva Recalls Carboplatin Injection Due to Sterility Risk

Teva Pharmaceuticals is recalling specific lots of Carboplatin Injection because the required reduction of endotoxin was not met, posing a sterility risk.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #D-928-2013Drug Teva Pharmaceuticals ›

Stop using this now

Lack of Assurance of Sterility: The required reduction of endotoxin was not met during the annual revalidation of the vial washer.

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Contact the company

Recalling firmTeva Pharmaceuticals USA, Inc.650 Cathill Rd · Sellersville, PA 18960-1512

✎ GovInfoNow plain-language explainer

Teva Pharmaceuticals USA, Inc. has recalled one lot of CARBOplatin Injection (600 mg/60ml) due to a lack of assurance of sterility. The issue arose because the required reduction of endotoxin was not met during the annual revalidation of the vial washer. This recall affects 780 vials distributed nationwide. Read more at govinfonow.com/recall/46693-teva-pharmaceuticals-usa-inc-recalls-carboplatin-injection-600-mg-60ml.

Source Summary by GovInfoNow · govinfonow.com/recall/46693-teva-pharmaceuticals-usa-inc-recalls-carboplatin-injection-600-mg-60ml · Updated October 13, 2026 · FDA enforcement record: FDA #D-928-2013

Cite this page

“Teva Recalls Carboplatin Injection Due to Sterility Risk.” GovInfoNow, updated October 13, 2026. https://govinfonow.com/recall/46693-teva-pharmaceuticals-usa-inc-recalls-carboplatin-injection-600-mg-60ml. Based on FDA recall #D-928-2013 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-928-2013%22&limit=1).

The FDA announced on 2013-08-13 that Teva Pharmaceuticals USA, Inc. voluntarily recalled CARBOplatin Injection due to a lack of assurance of sterility. The recall affects specific lots distributed nationwide.

How to tell if you have it

Brand: Teva Pharmaceuticals
Product: CARBOplatin Injection, 600 mg/60ml, MultiDose, Rx only
Manufacturer: Teva Parenteral Medicines, Inc., Irvine, CA 92618
NDC: 0703-3249-11
Lot codes: 31314458B (exp.08/14), 31314459B (exp.08/14), 31315794 (exp. 10/14), 31315982B (exp.11/14)
Distribution: Nationwide
Units affected: 780 vials

The hazard

The recall was issued because the required reduction of endotoxin was not met during the annual revalidation of the vial washer. This failure resulted in a lack of assurance of sterility for the drug product.

Context

GovInfoNow's records show Teva Pharmaceuticals USA, Inc. has 59 other recalls on record since 2012-04-02. Recent Teva recalls include traZODone 50mg tablets recalled on 2026-08-24 for the presence of foreign tablets and Claravis 10mg recalled on 2026-04-06 due to impurity issues. Other recent recalls of similar products include Cipla Lanreotide Injection Recall (2026-03-13) and Reliance Pemetrexed Injection Recall (2026-06-24).

How to tell if you have this one

Check if you have CARBOplatin Injection, 600 mg/60ml, MultiDose, Rx only, manufactured by Teva Parenteral Medicines, Inc. Look for NDC 0703-3249-11 and Lot number 31314458B with an expiration date of 08/14.

Brand
Teva Pharmaceuticals
Category
Drug

Based on the official FDA remedy

What to do — step by step

Stop using the product
Do not use the recalled CARBOplatin Injection vials immediately.
Contact your healthcare provider
If you have received or used this medication, contact your doctor or pharmacist for further instructions and potential replacement.

Where it went and when

Where it was distributed

Distributed nationwide.

FDA distribution: “Nationwide” States read from FDA’s own wording; “not listed” means the notice does not name it.

Distributed nationwide.

Recall timeline

FDA terminated this recall 12 months after the firm started it.

Aug 13, 2013Firm started the recall
Sep 3, 2013FDA classified it Class II
Sep 11, 2013Published in FDA’s Enforcement Report
Aug 27, 2014FDA terminated the recall

Dates from the agency record only; steps without a date are left out.

✎ GovInfoNow

Questions people ask

From the GovInfoNow team · based on the FDA notice · How we make summaries

How many units are affected by this recall?

A total of 780 vials are included in this recall.

Similar recalls

Other Teva Pharmaceuticals recalls

Keep exploring

Link to this recall

<a href="https://govinfonow.com/recall/46693-teva-pharmaceuticals-usa-inc-recalls-carboplatin-injection-600-mg-60ml">Teva Recalls Carboplatin Injection Due to Sterility Risk (GovInfoNow)</a>

Where this comes from

The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.

Official source: FDA Recall #D-928-2013 (August 13, 2013) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-928-2013 to see it in context.
Plain-language summary written by qwen3.6:35b-a3b on October 13, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.