The Recall Desk
ModerateFDA (Drugs)·D-0101-2023·Announced 2023-01-18

Moxifloxacin Ophthalmic Solution Recalled Due to Manufacturing Quality Deviation

Direct Rx recalled 11 bottles of Moxifloxacin Ophthalmic Solution (0.5%, 3 mL) due to a cGMP deviation and discontinued stability support.

What this means for you

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: This is an FDA Class II recall with no reported illnesses or injuries and no documented safety incident. The hazard is a manufacturing quality deviation with discontinued stability support, which constitutes a precautionary recall rather than an immediate known safety threat.

Plain-English summary

Direct Rx, LLC is recalling 11 bottles of Moxifloxacin Ophthalmic Solution, 0.5%, 3 mL (NDC 72189-0334-05, Lot #07MA2232, expiring 4/30/23) that were distributed in Florida. The recall was issued due to a current Good Manufacturing Practice (cGMP) deviation and the discontinuation of stability support for the product.

Patients who have this product should consult their healthcare provider about whether they may have been affected. The affected product should not be used. Patients with questions should contact Direct Rx, LLC at the address on the packaging or speak with their healthcare provider or pharmacist.

The recalled product

Product
Moxifloxacin Ophthalmic Solution, 0.5%, 3 mL, Rx Only, Packaged and Distributed By: Direct Rx, LLC 94 Worldwide Drive, Dawsonville, GA 30534, NDC 72189-0334-05
Manufacturer
Direct Rx
Category
Drug — Ophthalmic
Hazard
  • cgmp-deviation
  • product-stability

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 #: 07MA2232
  • Exp. 4/30/23

Distribution

Distributed in 1 state:

  • FL

Related recalls

Same category