The Recall Desk
CriticalFDA (Drugs)·D-0305-2015·Announced 2014-12-31

Pharmacy Creations Recalls Ascorbic Acid Injection Due to Sterility Failure

Pharmacy Creations is recalling 67 vials of Ascorbic Acid 500 mg/mL Sterile Injection because contract testing indicated the product may not be sterile.

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 severity score of 5 according to the rubric.

Plain-English summary

Pharmacy Creations is recalling 67 vials of Ascorbic Acid 500 mg/mL Sterile Injection, 50mL Multi-dose Vial. The recall was initiated after failing sterility results were obtained from the firm's contract testing facility, indicating that the products may not be sterile.

The affected product is prescription-only and was distributed directly to patients and physicians in Florida, New Jersey, New York, and Puerto Rico. The specific lot number is 05082014@7, with an expiration date of 11/04/2014.

Consumers and healthcare providers should stop using the recalled product and contact Pharmacy Creations at (973) 328-8756 for further instructions.

The recalled product

Product
Ascorbic Acid 500 mg/mL Sterile Injection, 50mL Multi-dose Vial, Rx only, Pharmacy Creations, Randolph, NJ 07869 (973) 328-8756.
Manufacturer
Pharmacy Creations
Affected units
67

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 #: 05082014@7
  • Exp 11/04/2014

Distribution

Distributed in 4 states:

Part of a larger recall action

This product is one of 4 recalled by Pharmacy Creations 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 4 products in this recall →