The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-1133-2017·Announced 2017-09-13

ImprimisRx Recalls Timolol Ophthalmic Drops Due to Undeclared Excipient

ImprimisRx is recalling compounded Timolol ophthalmic drops because they were made with non-pharmaceutical grade PEG 40 Castor Oil due to supplier mislabeling.

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 FDA classified this recall as Class II. Per the rubric, FDA Class II recalls are assigned a severity score of 4 (Severe), particularly when involving significant product defects like non-pharmaceutical grade ingredients.

Plain-English summary

ImprimisRx CA, Inc. is recalling two bottles of Timolol-Brimonidine-Dorzolamide-Latanoprost (0.5/0.15/2/0.005)% Ophthalmic Drops, Sterile 5ml Bottle. The product was compounded for licensed professional or patient use and distributed nationwide.

The recall was initiated because the product was manufactured using non-pharmaceutical grade PEG 40 Castor Oil. This occurred due to a mislabeling error by the supplier, resulting in an incorrect or undeclared excipient in the final product.

The FDA has classified this recall as Class II. Consumers and healthcare providers should stop using the affected product and contact their healthcare provider or the recalling firm for further instructions.

The recalled product

Product
Timolol-Brimonidine-Dorzolamide-Latanoprost (0.5/0.15/2/0.005)% Ophthalmic Drops, Sterile 5ml Bottle, Compounded for a licensed professional or patient use, imprimisRx, Irvine, CA
Manufacturer
ImprimisRx CA, Inc., dba ImprimisRx
Category
Drug — Ophthalmic
Hazard
Affected units
2

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)

  • 05092017@2B
  • 11/5/2017

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 4 recalled by ImprimisRx CA, Inc., dba ImprimisRx 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 4 products in this recall →

Related recalls

Same manufacturer · ImprimisRx CA, Inc., dba ImprimisRx

See all →

Same hazard · undeclared excipient

See all →

Similar recalls