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Recall Observatory FDA recall evidence

Drug product

Miocol-E (acetylcholine chloride intraocular solution) 20 mg/2mL (10 mg/mL), Rx only, Manufacturer: Bausch & Lomb, NDC 24208-539-20

D-0994-2022

April 13, 2022

Class II

Product summary

Firm
Mckesson Medical-Surgical Inc. Corporate Office
Event
Event 89646
Status
Terminated
Classification
Class II
Quantity
45 kits
Official record key
drug-enforcement:D-0994-2022

Official wording

Reason: cGMP deviations: Temperature abuse

Code information: 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. The letters clearly explain that consignees should identify product received from MMS between June 1 and September 30, 2021. A consignee should be able to use its own records to determine whether it received an impacted product from MMS during that timeframe and whether it still has any of that product in inventory. The recall notification letter informs consignees that they may contact Sedgwick if they have any questions.

Distribution pattern: USA nationwide.

Derived failure modes

  • Manufacturing or process control

    reason.manufacturing_process_control · v1.0.0

    cGMP deviations