FentaNYL Citrate PF, 500mcg/50 mL (10mcg/mL) in NACL, Injection for IV use, 50 mL syringe, STAQ Pharma Inc., 14135 E 42nd Ave, Denver, Colorado, NDC 73177-0102-05.
Labeling: Incorrect or Missing Lot and/or Exp Date
CooperVision recalled 90 units of Voyant 1-Day Premium Toric contact lenses on August 22, 2025. The recall affects one lot manufactured with an invalid sterilization cycle. Consumers should stop using the product immediately and follow recall instructions.
One lot manufactured with an invalid sterilization cycle.
Patients and healthcare providers should stop using this device immediately. Follow the recall instructions provided by the manufacturer. Contact CooperVision, Inc. or your healthcare provider for instructions. Notification method: Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
The recalled product is the Voyant 1-Day Premium Toric contact lens, model number Voyant 1-Day Premium Toric. The lenses have a water content of 54% and are made from cast molded Silicone Hydrogel. The affected carton lot number is 20735504301008 and the blister lot number is 6450505898.
The lenses were manufactured with an invalid sterilization cycle, which poses a risk of infection or other health issues. This recall falls under Class II, indicating a high risk to health.
There are no reported injuries or incidents related to the use of the recalled contact lenses at this time.
Stop using the recalled lenses immediately. Contact CooperVision or your healthcare provider for further instructions on how to return the product.
For more information, contact CooperVision at 1-800-341-2020 or visit their website. Additional details are available on the FDA enforcement report page.
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Labeling: Incorrect or Missing Lot and/or Exp Date
Labeling: Incorrect or Missing Lot and/or Exp Date
CGMP Deviations: The recalling firm filed for Chapter 11 on September 30, 2024. As a result, it cannot monitor the quality program and hence cannot assure that products meet the identity, strength, quality, and purity characteristics that they are purported or represented to possess, rendering the products adulterated.