The Recall Desk
SevereFDA (Drugs)·D-1088-2018·Announced 2018-08-22

Ranier's Medroxprogesterone Ophthalmic Solution Recalled for Sterility Concerns

Ranier's Compounding Laboratory is recalling Medroxprogesterone 1% Ophthalmic Solution due to a lack of assurance of sterility. The product was distributed in Pennsylvania.

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 agency classification is FDA Class II, and the hazard involves a lack of assurance of sterility in an ophthalmic product, which poses a significant risk of serious injury or infection.

Plain-English summary

Ranier's Compounding Laboratory is recalling Medroxprogesterone 1% Ophthalmic Solution, 10 mL droptainer, Rx only. The recall is due to a lack of assurance of sterility, as practices at the firm may call into question the sterility of products intended to be sterile.

The affected product was distributed within the state of Pennsylvania. All lots within expiry are included in this recall.

Consumers who have this product should stop using it and contact their healthcare provider or the recalling firm for further instructions.

The recalled product

Product
Medroxprogesterone 1% Ophthalmic Solution, 10 mL droptainer, Rx only, Ranier's Rx Laboratory, 1107 Lowry Avenue Suite A, Jeannette, PA 15644.
Affected units
1

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 (1)

  • All lots within expiry

Distribution

Distributed in 1 state:

Part of a larger recall action

This product is one of 15 recalled by Ranier's Compounding Laboratory 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 15 products in this recall →