The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-0778-2017·Announced 2017-05-24

Key Pharmacy Recalls Sodium Bicarbonate Injection Due to Sterility Concerns

Key Pharmacy and Compounding Center is recalling specific lots of Sodium Bicarbonate Injection because the firm cannot guarantee the product is 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 with potential for adverse health consequences (such as sterility issues in injectable drugs) are categorized as Severe.

Plain-English summary

Key Pharmacy and Compounding Center is recalling Sodium Bicarbonate 50ml MDV 8.4% Injection. The recall involves 2 vials of the product, specifically Lot # t01-26-2017@94, which has an expiration date of 4/27/2017. The product is a prescription-only injection prepared by the firm.

The recall was initiated due to a lack of assurance of sterility. The firm is recalling sterile compounded drugs within their expiry date because it cannot guarantee that the products are sterile. This is a Class II recall, indicating that use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences.

The affected product was distributed nationwide in the U.S.A., as well as in Australia and Canada. Consumers and healthcare providers should stop using the recalled product and contact their pharmacist or the recalling firm for further instructions.

The recalled product

Product
SODIUM BICARB 50ML MDV 8.4% (2 MOSMOL/ML) INJ, Injection, 8.40%, Rx only, 5mL Glass/Multiple Dose via, 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 (2)

  • Lot # t01-26-2017@94
  • Exp 4/27/2017

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