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.
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 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
- 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.
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