The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-0773-2017·Announced 2017-05-24

Key Pharmacy Recalls Procaine HCL Injections Due to Sterility Concerns

Key Pharmacy and Compounding Center is recalling Procaine HCL 1% 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 agency classification is FDA Class II. Per the rubric, FDA Class II recalls are assigned a severity score of 4 (Severe), particularly when involving sterile compounded drugs where sterility assurance is compromised.

Plain-English summary

Key Pharmacy and Compounding Center is recalling Procaine HCL SDV 1% INJ, a prescription-only injection packaged in 5mL and 50 mL glass single-dose vials. The recall involves 86 vials in total, comprising 78 5mL vials and 8 50mL vials. The affected lots have expiration dates ranging from May 21, 2017, to July 31, 2017.

The recall is being conducted due to a lack of assurance of sterility for the sterile compounded drugs. The firm is recalling these products within their expiry dates to address this quality concern.

The affected products were distributed nationwide in the United States, as well as in Australia and Canada. Consumers and healthcare providers should stop using the recalled vials and contact their healthcare provider or the recalling firm for further instructions.

The recalled product

Product
PROCAINE HCL SDV 1% INJ, Injection, 1%, Rx only, packaged in 5mL and 50 mL Glass/Single Dose vials, Prepared by Key Compounding Pharmacy
Manufacturer
Key Pharmacy and Compounding Center
Category
Drug — Compounded Sterile Drug
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 (10)

  • Lot # t11-21-2016@115
  • Exp 5/21/2017
  • t11-23-2016@109
  • Exp 5/27/2017
  • t12-13-2016@94
  • Exp 6/12/2017
  • t01-19-2017@85
  • Exp 7/22/2017
  • 02/01/2017@116
  • Exp 7/31/2017

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