The Recall Desk
Agency classClass IIOur severity:HighFDA (Drugs)·D-0708-2017·Announced 2017-05-24

Key Pharmacy Recalls 5-MTHF Injections Due to Sterility Concerns

Key Pharmacy and Compounding Center is recalling 5-MTHF 10mL multiple-dose vials due to a lack of assurance of sterility. The product was distributed in the U.S., Australia, and Canada.

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 3/5 (High).

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall is classified as FDA Class II, and the hazard involves a lack of assurance of sterility in a compounded drug, which poses a risk of harm without reported illnesses, fitting the High severity criteria.

Plain-English summary

Key Pharmacy and Compounding Center is recalling 5-MTHF 10ML MDV (CALIF) 5MG/ML INJ, a prescription-only sterile compounded drug. The recall involves 10mL glass multiple-dose vials containing 5mg/mL of 5-MTHF. The firm is recalling these products within their expiry dates due to a lack of assurance of sterility.

The affected lots include t11-17-2016@86, t12-22-2016@103, t01-09-2017@111, t01-11-2017@118, t01-18-2017@89, and t01-20-2017@83. The source text does not specify the total number of vials recalled, though the structured data indicates a quantity of 6 vials. The product was distributed nationwide in the U.S.A., as well as in Australia and Canada.

Consumers and healthcare providers should check their inventory for the specific lot numbers and expiration dates listed above. If the product is found, it should be discontinued and returned to the pharmacy or manufacturer for disposal. The source text does not report any illnesses or injuries associated with this recall.

The recalled product

Product
5-MTHF 10ML MDV (CALIF) 5MG/ML INJ, Injection, 5mg/mL, Rx only, 10mLGlass/Multiple Dose vial, Prepared by Key Compounding Pharmacy
Manufacturer
Key Pharmacy and Compounding Center
Category
Drug — Compounded Sterile Drug
Hazard
Affected units
6

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 (12)

  • Lot # t11-17-2016@86
  • Exp 5/17/2017
  • t12-22-2016@103
  • Exp 7/4/2017
  • t01-09-2017@111
  • Exp 7/9/2017
  • t01-11-2017@118
  • Exp 7/11/2017
  • t01-18-2017@89
  • Exp 7/18/2017
  • t01-20-2017@83
  • Exp 7/23/2017.

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 →

Related recalls

Same manufacturer · Key Pharmacy and Compounding Center

See all →

Same hazard · sterility

See all →

Similar recalls