The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Drugs)·D-1132-2017·Announced 2017-09-13

ImprimisRx Recalls Timolol-Latanoprost Ophthalmic Drops Due to Mislabeling

ImprimisRx is recalling 16 bottles of compounded Timolol-Latanoprost ophthalmic drops because non-pharmaceutical grade PEG 40 Castor Oil was used 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 2/5 (Moderate).

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: The recall is classified as FDA Class II, and the source text describes a labeling error involving non-pharmaceutical grade ingredients without reporting specific injuries or illnesses, fitting the criteria for a moderate severity voluntary precautionary recall.

Plain-English summary

ImprimisRx CA, Inc., dba ImprimisRx, is recalling 16 bottles of Timolol-Latanoprost PF Solution (0.5-0.005)%, Ophthalmic Drops, Sterile 5ml Bottle. The product was compounded for licensed professional or patient use and distributed nationwide.

The recall was initiated because an incorrect or undeclared excipient was used in the product. Specifically, non-pharmaceutical grade PEG 40 Castor Oil was utilized due to a mislabeling error by the supplier.

Consumers and healthcare professionals who have this product should stop using it and contact ImprimisRx for further instructions or a return.

The recalled product

Product
Timolol-Latanoprost PF Solution (0.5-0.005)%, 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
16

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)

  • 04042017@34B
  • 10/01/2017

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 →

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