The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-0719-2017·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 MDV 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 recall is classified as FDA Class II, and the hazard involves a lack of assurance of sterility in an injectable drug, which poses a significant risk of serious injury or hospitalization if contaminated.

Plain-English summary

Key Pharmacy and Compounding Center is recalling Folinic Acid MDV Injection, 10 mg/mL, packaged in 2mL and 10 mL glass multiple-dose vials. The recall involves 12 vials total, consisting of three 2mL vials and nine 10mL vials. The affected lots are identified as Lot # t01-31-2017@128 (Exp 5/2/2017) and Lot # 01-31-2017@118 (Exp 5/1/2017).

The recall was initiated because the firm could not ensure the sterility of the compounded drugs. The source text does not report any specific illnesses or injuries associated with the use of these products.

The affected products were distributed nationwide in the U.S.A., as well as in Australia and Canada. Patients and healthcare providers should check their inventory for these specific lot numbers and expiration dates. If found, the products should be discontinued and returned to the pharmacy or manufacturer for disposal.

The recalled product

Product
FOLINIC ACID MDV INJ, Injection, 10 mg/mL, Rx only, packaged in 2mL and 10 mL glass/Multiple Dose vials, Prepared by Key Compounding Pharmacy
Manufacturer
Key Pharmacy and Compounding Center
Category
Drug — Compounded Injectable
Hazard

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 (4)

  • Lot # t01-31-2017@128
  • Exp 5/2/2017
  • 01-31-2017@118
  • Exp 5/1/2017.

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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