The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-0712-2017·Announced 2017-05-24

Key Pharmacy Recalls Atropine Sulfate Ophthalmic Solution Due to Sterility Concerns

Key Pharmacy and Compounding Center is recalling Atropine Sulfate 0.5% Ophthalmic Solution because the firm cannot assure the sterility of the product.

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 sterile compounded drug where sterility assurance is lacking is categorized as Severe (Score 4), as it poses a significant risk of infection or injury.

Plain-English summary

Key Pharmacy and Compounding Center is recalling Atropine Sulfate 0.5% Ophthalmic Solution, a prescription-only ophthalmic product prepared in 15 mL glass multiple-dose vials. The recall is being conducted because the firm lacks assurance of the sterility of the compounded drugs within their expiration date.

The affected product is identified by Lot # t01-26-2017@93 and has an expiration date of 4/27/2017. The source text indicates that the 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 healthcare provider or the recalling firm for further instructions on disposal or replacement.

The recalled product

Product
ATROPINE SULFATE 0.5% OPHTH, Ophthalmic 0.50%, Rx only, 15mlLGlass /Multiple Dose vial, Prepared by Key Compounding Pharmacy
Manufacturer
Key Pharmacy and Compounding Center
Category
Drug — Ophthalmic
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 # t01-26-2017@93
  • 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 →

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