The Recall Desk
SevereFDA (Drugs)·D-0210-2019·Announced 2018-11-07

Pharm D Solutions Recalls Vigamox Ophthalmic Solution Due to Sterility Concerns

Pharm D Solutions is recalling 521 syringes of Vigamox Ophthalmic Solution nationwide 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 recall is classified as FDA Class II, which corresponds to a Severe severity score under the rubric for significant injury or health risk scenarios.

Plain-English summary

Pharm D Solutions, LLC is recalling 521 syringes of Vigamox Oph. Solution (NDC 69699-0304-05) distributed nationwide. The recall was initiated because of a lack of assurance of sterility for the affected product.

The recall covers specific lots with the following discard dates: Lot 04192018:22 (Discard by 5/17/2018), Lot 04022018:47 (Discard by 4/23/2018), Lot 05102018:77 (Discard by 6/7/2018), Lot 08022018:63 (Discard by 8/30/2018), and Lot 08272018:66 (Discard by 9/24/2018).

Consumers and healthcare providers should stop using the affected product and contact Pharm D Solutions, LLC for further instructions or a refund.

The recalled product

Product
Vigamox Oph. Solution Pharm D Solutions, Houston, Texas --- NDC 69699-0304-05
Hazard
Affected units
521

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 (5)

  • Lot: 04192018:22 Discard by: 5/17/2018
  • 04022018:47 Discard by: 4/23/2018
  • 05102018:77 Discard by: 6/7/2018
  • 08022018:63 Discard by: 8/30/2018
  • 08272018:66 Discard by: 9/24/2018

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 79 recalled by Pharm D Solutions, 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 79 products in this recall →