The Recall Desk
SevereFDA (Drugs)·D-0758-2017·Announced 2017-05-24

Key Pharmacy Recalls Alpha Lipoic Acid Injection Due to Sterility Concerns

Key Pharmacy and Compounding Center is recalling Alpha Lipoic Acid injections due to a lack of assurance of sterility. The affected product was distributed in the U.S., Australia, and Canada.

What this means for you

Illness, injury, or structural failure has been reported. 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 sterile drug with a lack of assurance of sterility is categorized as Severe (Score 4) due to the potential for significant injury from infection.

Plain-English summary

Key Pharmacy and Compounding Center is recalling a specific lot of Alpha Lipoic Acid 25mg/mL injection. The product is a prescription-only, 25 mL glass multiple-dose vial prepared by the firm.

The recall was initiated because the firm lacks assurance of the sterility of the compounded drug. The affected product is identified by Lot # t02-22-2017@96 and has an expiration date of 5/24/2017.

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

The recalled product

Product
ALPHA LIPOIC ACID 25ML MDV 25MG/ML INJ, Injection, 25mg/mL, Rx only, 25 mL Glass/Multiple Dose vial, Prepared by Key Compounding Pharmacy
Manufacturer
Key Pharmacy and Compounding Center
Category
Drug — Compounded Sterile Drug
Hazard
Affected units
1

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 # t02-22-2017@96
  • Exp 5/24/2017

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

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Same hazard · lack of sterility

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