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.
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: 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
- 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 →Related recalls
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