The Recall Desk
HighFDA (Drugs)·D-1578-2019·Announced 2019-08-07

ImprimisRx Recalls Subpotent Timolol-Latanoprost Ophthalmic Drops Nationwide

ImprimisRx NJ is voluntarily recalling 405 bottles of Timolol-Latanoprost P-F ophthalmic drops because the medication was found to be subpotent.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall is classified as FDA Class II for a subpotent drug, which fits the rubric criterion for risk-of-harm products where injury has not yet been reported.

Plain-English summary

ImprimisRx NJ has initiated a voluntary recall of 405 bottles of Timolol-Latanoprost P-F (0.5/0.005%) ophthalmic drops. The product is packaged in 5mL bottles and is available by prescription only. The recall was initiated because the medication was identified as subpotent, meaning it did not contain the full amount of active ingredient required.

The affected product was distributed nationwide within the United States. The recall covers three specific lots: Lot 01252019@1 with an expiration date of 07/21/2019; Lot 03182019@7 with an expiration date of 09/7/2019; and Lot 05092019@2 with an expiration date of 11/2/2019. The recall was initiated on July 17, 2019, and the status is currently terminated.

Consumers who have this product should check their bottles for the specific lot numbers and expiration dates listed above. If the product matches the recalled lots, consumers should contact their healthcare provider or pharmacist for guidance on how to dispose of the medication or obtain a replacement. The recall was classified as Class II by the FDA, indicating a reasonable probability that the use of the product could cause temporary or medically reversible health consequences.

The recalled product

Product
Timolol-Latanoprost P-F (0.5/0.005%) ophthalmic drops, packaged in 5mL bottles, Rx only, ImprimisRX NJ 1705 Route 46 West, Suite 4, Ledgewood, NJ 07852 (844) 446-6979
Manufacturer
ImprimisRx NJ
Affected units
405

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 (6)

  • Lot #:01252019@1
  • Exp. 07/21/2019
  • 03182019@7
  • Exp. 09/7/2019
  • 05092019@2
  • Exp. 11/2/2019

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 2 recalled by ImprimisRx NJ 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 2 products in this recall →