The Recall Desk
Agency classClass IIOur severity:HighFDA (Drugs)·D-0772-2017·Announced 2017-05-24

Key Pharmacy Recalls Procaine HCL Injections Due to Sterility Concerns

Key Pharmacy and Compounding Center is recalling specific lots of Procaine HCL 1% injections because the firm cannot ensure 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 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 involves a sterile compounded drug with a lack of assurance of sterility, which poses a risk of harm (infection) even though no specific illnesses have been reported in the source text. This aligns with the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.

Plain-English summary

Key Pharmacy and Compounding Center is recalling 40 vials of Procaine HCL 1% Injection, 5mL Glass/Single Dose vials. The recall affects two specific lots: Lot # t01-13-2017@84 (Expiration 4/18/2017) and Lot # 02-02-2017@97 (Expiration 5/3/2017). These products were prepared by Key Compounding Pharmacy and 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 within their expiration dates because it cannot guarantee that the products are sterile. The source text does not report any specific illnesses or injuries associated with this recall.

Consumers and healthcare providers should check their inventory for the specific lot numbers and expiration dates listed above. If you have these products, you should stop using them and contact the recalling firm or your healthcare provider for instructions on how to return or dispose of the medication.

The recalled product

Product
PROCAINE HCL *5ML* SDV SULFITE FREE 1% INJ, Injection, 1%, RXxonly, 5mL Glass/Single Dose vials, Prepared by Key Compounding Pharmacy
Manufacturer
Key Pharmacy and Compounding Center
Category
Drug — Compounded Sterile Drug
Hazard
Affected units
40

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 # t01-13-2017@84
  • Exp 4/18/2017
  • 02-02-2017@97
  • Exp 5/3/2017

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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