ImprimisRx Recalls Latanoprost Ophthalmic Drops Due to Undeclared Excipient
ImprimisRx is recalling 19 bottles of compounded Latanoprost ophthalmic drops because they contain non-pharmaceutical grade PEG 40 Castor Oil 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/excipient error without reporting specific injuries or illnesses, fitting the criteria for a moderate severity voluntary precautionary recall.
Plain-English summary
ImprimisRx CA, Inc. is recalling 19 bottles of Latanoprost PF Solution, 0.005%, Ophthalmic Drops in sterile 5ml bottles. The product was compounded for licensed professional or patient use and distributed nationwide.
The recall was initiated because the product contains an incorrect and undeclared excipient. Specifically, non-pharmaceutical grade PEG 40 Castor Oil was used in the formulation due to a mislabeling error by the supplier.
The affected product is identified by the code 0404017@32B with a date of 10/01/2017. Consumers and healthcare professionals should stop using the product and contact their pharmacist or the recalling firm for further instructions.
The recalled product
- Product
- Latanoprost PF Solution, 0.005%, Ophthalmic Drops in Sterile 5ml Bottles, Compounded for a licensed professional or patient use, imprimisRx, Irvine, CA
- Manufacturer
- ImprimisRx CA, Inc., dba ImprimisRx
- Category
- Drug — Ophthalmic
- Affected units
- 19
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)
- 0404017@32B
- 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.
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