The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-0709-2017·Announced 2017-05-24

Key Pharmacy Recalls 5-MTHF Injection Due to Sterility Concerns

Key Pharmacy and Compounding Center is recalling 5-MTHF 10mL single-dose vials because the firm cannot assure the sterility of the product.

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 death if contaminated.

Plain-English summary

Key Pharmacy and Compounding Center is recalling 5-MTHF 10ML SDV (CALIF) 5MG/ML INJ, a prescription-only injection prepared in 10mL glass single-dose vials. The recall involves 3 vials from Lot # t12-28-2016@113, which has an expiration date of 6/27/2017.

The firm is recalling these sterile compounded drugs because there is a lack of assurance of sterility. The product was distributed nationwide in the U.S.A., as well as in Australia and Canada.

Consumers and healthcare providers should stop using the affected product and contact their healthcare provider or the recalling firm for further instructions.

The recalled product

Product
5-MTHF 10ML SDV (CALIF) 5MG/ML INJ, Injection 5mg/mL, Rx only, 10mL Glass /Single Dose vial, Prepared by Key Compounding Pharmacy
Manufacturer
Key Pharmacy and Compounding Center
Category
Drug — Compounded Injectable
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 (2)

  • Lot # t12-28-2016@113
  • Exp 6/27/2017.

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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