The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-0756-2017·Announced 2017-05-24

Key Pharmacy Recalls PGE1/Procaine Injections Due to Sterility Concerns

Key Pharmacy and Compounding Center is recalling specific lots of PGE1/Procaine 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, an FDA Class II recall involving a significant hazard such as lack of sterility in an injectable drug corresponds to a severity score of 4 (Severe).

Plain-English summary

Key Pharmacy and Compounding Center is voluntarily recalling specific lots of PGE1/Procaine 5ml multiple-dose vials. The recall is being conducted because the firm lacks assurance of the sterility of these compounded drugs.

The affected product is a prescription-only injection containing 20mcg/ml of PGE1 and 0.1% Procaine. The recall covers three vials per unit. The specific lots affected are t12-12-2016@92 (expiring May 22, 2017) and t02-14-2017@103 (expiring August 2, 2017).

These products were distributed nationwide in the United States, as well as in Australia and Canada. Patients and healthcare providers should stop using the affected lots and contact their pharmacist or the recalling firm for further instructions.

The recalled product

Product
PGE1/PROCAINE 5ML MDV 20MCG/ML/0.1% INJ, Injection, 20mcg/ml 0.1%, Rx only, 5 mL Glass/Multiple Dose vial, Prepared by Key Compounding Pharmacy
Manufacturer
Key Pharmacy and Compounding Center
Category
Drug — Compounded Injectable
Hazard
Affected units
3

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 # t12-12-2016@92
  • Exp 5/22/2017
  • t02-14-2017@103
  • Exp 8/2/2017

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