The Recall Desk
SevereFDA (Drugs)·D-0687-2017·Announced 2017-05-03

Isomeric Pharmacy Recalls Phenylephrine and Tropicamide Ophthalmic Drops

Isomeric Pharmacy Solution, LLC is recalling 5,165 bottles of Phenylephrine 2.5% and Tropicamide 1% ophthalmic drops due to a lack of assurance of sterility.

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 FDA classified this recall as Class II. Per the rubric, FDA Class II recalls with potential for adverse health consequences (such as sterility failures in ophthalmic products) are categorized as Severe.

Plain-English summary

Isomeric Pharmacy Solution, LLC is recalling 5,165 bottles of Phenylephrine 2.5%, Tropicamide 1%, 15 mL Multi-Dose Ophthalmic Drops. The product is prescription-only and was distributed nationwide in the USA and Puerto Rico. The recall covers specific lot numbers with expiration dates ranging from April 2017 to July 2017.

The recall was initiated due to concerns with production processes that cannot assure the sterility of products intended to be sterile. The FDA has classified this recall as Class II, indicating that use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

Consumers and healthcare providers should stop using the affected product and contact their healthcare provider for further instructions. The product is identified by Part # 1300 and barcode 3 70285 13001 4.

The recalled product

Product
Phenylephrine 2.5%, Tropicamide 1%, 15 mL Multi-Dose Ophthalmic (spelled Opthalmic) Drops in a bottle, Rx Only, Isomeric Pharmacy Solutions, 2401 Foothill Dr, SLC, UT 84109, Part # 1300, barcode 3 70285 13001 4.
Manufacturer
Isomeric Pharmacy Solution, LLC
Category
Drug — Ophthalmic
Hazard
Affected units
5,165

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 (20)

  • Lot Numbers: 10003
  • Exp 04/05/17
  • 10018
  • Exp 04/17/17
  • 10023
  • Exp 04/23/17
  • 10025
  • Exp 04/24/17
  • 10027
  • Exp 04/29/17
  • 11011
  • 11012
  • Exp 05/07/17
  • 11024
  • 11026
  • Exp 05/14/17
  • 11029
  • Exp 05/16/17
  • 11030
  • Exp 05/17/17

Distribution

Distributed nationwide across the United States.

The notice also names 1 state specifically:

Part of a larger recall action

This product is one of 7 recalled by Isomeric Pharmacy Solution, LLC 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 7 products in this recall →

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Same hazard · sterility failure

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