The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-0718-2017·Announced 2017-05-24

Key Pharmacy Recalls Folinic Acid Injections Due to Sterility Concerns

Key Pharmacy and Compounding Center is recalling specific lots of Folinic Acid injections because the firm cannot guarantee the products are sterile.

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 recall is classified as FDA Class II and involves a lack of assurance of sterility in compounded drugs, which poses a significant risk of infection or serious injury, meeting the criteria for a Severe rating.

Plain-English summary

Key Pharmacy and Compounding Center is recalling Folinic Acid MDV (CALIF) 5MG/ML INJ, a prescription-only injection packaged in 5 mL and 10 mL glass multiple-dose vials. The recall involves three specific vials identified by lot numbers t02-09-2017@74, t02-17-2017@89, and t02-20-2017@72. These products were distributed nationwide in the U.S.A., as well as in Australia and Canada.

The recall was initiated due to a lack of assurance of sterility. The firm is recalling these sterile compounded drugs, which are within their expiry dates, because it cannot verify that they remain sterile. The agency has classified this recall as Class II.

Consumers and healthcare providers should check their inventory for the specific lot numbers and expiration dates listed above. If these products are found, they should be returned to the pharmacy or the recalling firm for disposal or credit, as directed by the recall notice.

The recalled product

Product
FOLINIC ACID MDV (CALIF) 5MG/ML INJ, Injection, 5mg/mL, Rx only, packaged in 5 mL and10 mL glass/ Multiple Dose vial, Prepared by Key Compounding Pharmacy
Manufacturer
Key Pharmacy and Compounding Center
Category
Drug — Compounded Sterile Drug
Hazard
Affected units
3

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 (6)

  • Lot # t02-09-2017@74
  • Exp 5/15/2017
  • t02-17-2017@89
  • Exp 5/21/2017
  • t02-20-2017@72
  • Exp 5/22/2017.

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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