The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-0759-2017·Announced 2017-05-24

Key Pharmacy Recalls Sterile Ophthalmic Compounded Drug Due to Sterility Concerns

Key Pharmacy and Compounding Center is recalling a specific lot of sterile compounded ophthalmic drug due to a 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 assurance of sterility in a sterile compounded drug, which poses a significant risk of infection or serious injury.

Plain-English summary

Key Pharmacy and Compounding Center is recalling a specific lot of VIT C/GSH 1.25%-1.25% OPHTH, a sterile compounded ophthalmic drug. The product is a prescription-only, 15 mL plastic multiple-dose bottle prepared by the firm. The recall is being conducted due to a lack of assurance of sterility for the sterile compounded drugs within their expiry date.

The affected product is identified by Lot # 02-23-2017@35 with an expiration date of 4/24/2017. The source text indicates that the product was distributed nationwide in the U.S.A., as well as in Australia and Canada. The source text does not specify the number of units affected or report any illnesses or injuries associated with the product.

Consumers and healthcare providers should check their inventory for the specific lot number and expiration date listed above. If the product matches the recalled lot, it should be discontinued from use and returned to the pharmacy or disposed of according to local regulations. The source text does not provide specific contact information for the recalling firm or instructions for disposal.

The recalled product

Product
VIT C/GSH 1.25%-1.25% OPHTH, Ophthalmic, 1.25%, Rx only, 15 mL Plastic/ Multiple Dose bottle, 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 (2)

  • Lot # 02-23-2017@35
  • Exp 4/24/2017

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 →

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