The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-0710-2017·Announced 2017-05-24

Key Pharmacy Recalls 5-MTHF Injections Due to Sterility Concerns

Key Pharmacy and Compounding Center is recalling 5-MTHF SDV 5mg/mL injections because the firm cannot assure the sterility of the compounded drugs.

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, which corresponds to a Severe rating under the rubric, particularly given the risk of infection associated with a lack of sterility assurance in injectable drugs.

Plain-English summary

Key Pharmacy and Compounding Center is recalling 5-MTHF SDV 5MG/ML INJ, a prescription-only injection packaged in 1 mL, 2 mL, 5 mL, and 10 mL glass single-dose vials. The recall involves 63 vials total, distributed nationwide in the U.S.A., Australia, and Canada.

The recall was initiated due to a lack of assurance of sterility for the sterile compounded drugs within their expiry dates. The affected lots include specific expiration dates ranging from June 2017 to August 2017.

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

The recalled product

Product
5-MTHF SDV 5MG/ML INJ, Injection, 5mg/mL, Rx only, packaged in 1 mL, 2 mL, 5 mL, and 10 mL Glass/Single 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 (16)

  • Lot # t12-05-2016@116
  • Exp 6/4/2017
  • t12-15-2016@84
  • Exp 6/14/2017
  • t12-23-2016@67
  • Exp 6/25/2017
  • t12-28-2016@105
  • Exp 6/27/2017
  • t01-30-2017@88
  • Exp 7/30/2017
  • t02-06-2017@109
  • Exp 8/6/2017
  • t02-14-2017@92
  • Exp 8/14/2017
  • t02-20-2017@79
  • Exp 8/20/2017

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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