The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-0774-2017·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 2% injections because the firm cannot guarantee 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 recall is classified as FDA Class II. According to the rubric, FDA Class II recalls involving significant injury reports or structural defects are rated as Severe (4). While no specific injuries are reported in the text, the lack of sterility assurance in a compounded drug is a significant safety hazard that fits the Class II criteria for a higher severity rating than moderate.

Plain-English summary

Key Pharmacy and Compounding Center is recalling Procaine HCL SDV 2% Injection, a prescription-only medication packaged in 10mL and 50 mL glass single-dose vials. The recall involves a total of 9 vials, consisting of three 10mL vials and six 50mL vials.

The firm is recalling these sterile compounded drugs because there is a lack of assurance of sterility. The affected products are within their expiration dates. The specific lots involved are t01-25-2017@122 (Exp 4/26/2017), t12-12-2016@98 (Exp 6/11/2017), and t01-10-2017@119 (Exp 7/10/2017).

The products were distributed nationwide in the U.S.A., as well as in Australia and Canada. Consumers and healthcare providers should check their inventory for these specific lot numbers and expiration dates. If found, the products should not be used and should be returned to the pharmacy or the recalling firm.

The recalled product

Product
PROCAINE HCL SDV 2% INJ, Injection, 2%, Rx only, packaged in 10mL 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 (6)

  • Lot # t01-25-2017@122
  • Exp 4/26/2017
  • t12-12-2016@98
  • Exp 6/11/2017
  • t01-10-2017@119
  • Exp 7/10/2017

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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