The Recall Desk
HighFDA (Drugs)·D-1340-2015·Announced 2015-09-09

Artesunate Injection Recalled for Potential Penicillin Cross Contamination

South Coast Specialty Compounding is recalling 172 vials of Artesunate Lyophilized Powder for Injection due to potential penicillin cross-contamination.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall involves a high-risk allergen (penicillin) cross-contamination in a drug product, which fits the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.

Plain-English summary

South Coast Specialty Compounding, Inc. is recalling 172 vials of Artesunate Lyophilized Powder for Injection, 60 mg per vial. The product is a prescription-only medication manufactured by Park Compounding in Irvine, California. The recall involves specific lots with expiration dates ranging from June 2015 to August 2015.

The recall was initiated because multiple finished products were potentially contaminated with penicillin. This cross-contamination poses a risk to patients with penicillin allergies. The affected product was distributed nationwide.

Healthcare providers and patients should stop using the affected vials immediately. Patients should consult their healthcare provider for alternative treatment options if they have been prescribed this medication.

The recalled product

Product
Artesunate Lyophilized Powder for Injection, 60 mg per vial, Rx only, Manufactured by Park Compounding, Irvine, CA
Manufacturer
South Coast Specialty Compounding, Inc.
Category
Drug — Antimalarial
Hazard

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 (5)

  • Lot # 12032014@2B
  • Exp.06/15 Lot # 12072014@3B
  • Exp.06/15 Lot # 01032015@2B
  • Exp.07/15 Lot # 02152015@2B
  • Exp.08/15

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 15 recalled by South Coast Specialty Compounding, Inc. under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 15 products in this recall →

Related recalls

Same manufacturer · South Coast Specialty Compounding, Inc.

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Same hazard · allergen penicillin

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