The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-0760-2017·Announced 2017-05-24

FDA Recalls Compounded Injection Due to Lack of Sterility Assurance

Key Pharmacy and Compounding Center is recalling CHOL/IN/ME(L)/B6 10ML MDV injection due to lack of assurance of sterility.

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, and the hazard involves a lack of sterility assurance in an injectable drug, which poses a significant risk of infection or serious injury.

Plain-English summary

Key Pharmacy and Compounding Center is recalling CHOL/IN/ME(L)/B6 10ML MDV 50/50/25/0.1MG/ML INJ, a prescription-only compounded injection. The product is a 10mL glass multiple-dose vial prepared by the firm.

The recall was initiated due to a lack of assurance of sterility for the sterile compounded drugs within their expiry date. The specific lot number is t02-06-2017@107, with an expiration date of 4/30/2017.

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

The recalled product

Product
CHOL/IN/ME(L)/B6 10ML MDV 50/50/25/0.1MG/ML INJ, Injection, 50mg/50mg/25mg/0.1mg/mL, Rx only, 10mL Glass/Multiple Dose vial, Prepared by Key Compounding Pharmacy
Manufacturer
Key Pharmacy and Compounding Center
Category
Drug — Compounded Injectable
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 (3)

  • Lot # t02-06-2017@107
  • Exp 4/30/2017 Lot t02-06-2017@107
  • Expiry date 4/30/2017

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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