The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-0717-2017·Announced 2017-05-24

Key Pharmacy Recalls Folic Acid Injection Due to Sterility Concerns

Key Pharmacy and Compounding Center is recalling 20 vials of Folic Acid 10mg/mL injection due to a lack of assurance of sterility.

The agency’s classification

FDA (Drugs): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

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 4/5 (Severe).

The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The FDA classified this recall as Class II. According to the severity rubric, an FDA Class II recall involving a sterile drug with a lack of assurance of sterility (a significant safety risk) corresponds to a score of 4 (Severe), as it falls under the criteria for significant injury risk or high-risk contamination without confirmed fatalities.

Plain-English summary

Key Pharmacy and Compounding Center is recalling 20 vials of Folic Acid 1ML SDV 10MG/ML INJ, Injection, 10mg/mL, Rx only, 1 mL glass/Single Dose vial. The recall is being conducted because the firm lacks assurance of the sterility of the compounded drugs within their expiry date.

The affected product, Lot # t01-20-2017@80 with an expiration date of 4/23/2017, was distributed nationwide in the U.S.A., Australia, and Canada. The FDA has classified this recall as Class II, indicating that use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences.

Consumers and healthcare providers should discontinue use of the affected vials and contact their pharmacist or the recalling firm for further instructions on disposal or replacement.

The recalled product

Product
FOLIC ACID 1ML SDV 10MG/ML INJ, Injection, 10mg/mL, Rx only, 1 mL glass/Single Dose vial, Prepared by Key Compounding Pharmacy
Manufacturer
Key Pharmacy and Compounding Center
Category
Drug — Compounded Sterile Drug
Hazard
Affected units
20

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 # t01-20-2017@80
  • Exp 4/23/2017

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 79 recalled by Key Pharmacy and Compounding Center 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 79 products in this recall →

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