The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-0771-2017·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 assure 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 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 agency classified this as an FDA Class II recall. Per the rubric, FDA Class II recalls involving significant injury/property-damage reports or structural defects are rated Severe; while no specific injuries are reported in the text, the lack of sterility assurance in a sterile compounded drug represents a significant risk of harm consistent with the Severe criteria for Class II recalls.

Plain-English summary

Key Pharmacy and Compounding Center is recalling two vials of Procaine HCL 50ML MDV (CALIF) 1% INJ, a prescription-only injection prepared in 50mL glass multiple-dose vials. The recall involves specific lots with expiration dates of April 19, 2017, and April 26, 2017.

The firm is conducting this recall due to a lack of assurance of sterility for the compounded drugs. The affected products were distributed nationwide in the U.S.A., as well as in Australia and Canada.

Consumers and healthcare providers should stop using the affected vials and contact the recalling firm or their healthcare provider for instructions on how to return or dispose of the product.

The recalled product

Product
PROCAINE HCL 50ML MDV (CALIF) 1% INJ, Injection, 1%, Rx only, 50mL Glass/Multiple Dose vial, Prepared by Key Compounding Pharmacy
Manufacturer
Key Pharmacy and Compounding Center
Category
Drug — Compounded Sterile Drug
Hazard
Affected units
2

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 # t01-18-2017@94
  • Exp 4/19/2017
  • t01-25-2017@115
  • Exp 4/26/2017

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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