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.
The agency’s classification
FDA (Drugs): Class I
Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
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 5/5 (Critical).
Highest-severity recall. The hazard can cause serious injury or death. 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
- Category
- Drug — Sterile Injection
- 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
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