The Recall Desk
CriticalFDA (Drugs)·D-1546-2014·Announced 2014-08-27

Pharmacy Creations Recalls Ascorbic Acid Injection Vials Due to Mold Contamination

Pharmacy Creations is recalling 70 vials of Ascorbic Acid 500 mg/mL sterile injection due to mold contamination. The affected product was distributed in New York, New Jersey, and Puerto Rico.

What this means for you

Highest-severity recall. Risk of serious injury or death is documented or strongly suspected. Stop using the product now and follow the agency's instructions.

Our severity reasoning: The agency classification is FDA Class I, which mandates a minimum severity score of 4, and the presence of mold contamination in a sterile injection represents a critical risk of serious injury or death, aligning with the criteria for a score of 5.

Plain-English summary

Pharmacy Creations is recalling 70 vials of Ascorbic Acid 500 mg/mL Sterile Injection, 50 mL Multi-dose Vial, due to mold contamination. The product is a prescription-only sterile injection manufactured in Randolph, New Jersey.

The recall involves Lot 06062014@8, with a 'Do Not Use Beyond' date of 12/03/2014. The affected vials were distributed in New York, New Jersey, and Puerto Rico.

Consumers and healthcare providers should stop using the affected product and contact their healthcare provider or pharmacist for further instructions.

The recalled product

Product
Ascorbic Acid 500 mg/mL Sterile Injection, 50 mL Multi-dose Vial, Rx only, Pharmacy Creations, Randolph, NJ 07869.
Manufacturer
Pharmacy Creations
Affected units
70

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 (2)

  • Lot: 06062014@8
  • Do Not Use Beyond 12/03/2014

Distribution

Distributed in 3 states: