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FDA (Drug enforcement)Recalled 2022-04-13closedclass ii

Mckesson Medical-Surgical Inc. Corporate Office: Tetracaine Hydrochloride Ophthalmic Solution, 0.5%, 4 mL bottle, Rx only, MFG: Alcon Surgical Inc., NDC 0065-0741-14

Is my product affected?

Tetracaine Hydrochloride Ophthalmic Solution, 0.5%, 4 mL bottle, Rx only, MFG: Alcon Surgical Inc., NDC 0065-0741-14

  • Brand TETRACAINE HYDROCHLORIDE

Check against the official notice below — it lists the full affected range.

What happened

McKesson Medical-Surgical Inc. is recalling Tetracaine Hydrochloride Ophthalmic Solution, 0.5%, in 4 mL bottles (a prescription eye anesthetic made by Alcon Surgical Inc.) distributed nationwide. The recall affects 43 cartons containing 12 blister packs due to temperature abuse during storage or handling that violated manufacturing quality standards.

McKesson was unable to identify which specific lot numbers were received by individual customers, so the company provided distribution dates to affected recipients to help determine if they received impacted product. The source does not specify a remedy for affected consumers.

Written by software from the official notice below. Not reviewed by a lawyer.

Hazard

cGMP deviations: Temperature abuse

Details from the source

Reason for recall: cGMP deviations: Temperature abuse Distribution: USA nationwide. Quantity: 43 cartons/12 blister packs Lot/code info: McKesson Medical-Surgical (MMS) is not able to identify the particular lot number received by a particular consignee for the recalled prescription products. Each letter includes the date it was distributed to customers and the dates that impacted product may have been shipped to the customer.

Source

Official record: FDA (Drug enforcement) ↗

Republished from the official source above; details can change — the source record controls.

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