FDA Class II Recall: Miochol E Intraocular Solution Due to Temperature Exposure
McKesson is recalling Miochol E intraocular solution due to temperature abuse during distribution. The product should not be used if received between June 1 and September 30, 2021.
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: FDA Class II recall involving temperature abuse of a sterile intraocular injection product, which could compromise product sterility and efficacy. While no illnesses or injuries are reported, the inherent risk to eye health from a compromised sterile intraocular product warrants a High severity classification.
Plain-English summary
McKesson Medical-Surgical Inc. is recalling Miochol E (acetylcholine chloride intraocular solution) 20 mg/2 mL (10 mg/mL), NDC 24208-539-20, manufactured by Bausch & Lomb, due to cGMP deviations involving temperature abuse. A total of 45 kits were affected.
The product was distributed nationwide to healthcare facilities and providers between June 1 and September 30, 2021. Temperature abuse during manufacturing or distribution may compromise the product's integrity and sterility assurance. Specific lot numbers cannot be identified by the distributor, so affected customers must check their own records.
Healthcare facilities and prescribers who received product from McKesson during the specified timeframe should verify their own inventory records to identify whether any recalled product is still in stock. Facilities should not use any product identified as received during this period.
For questions regarding the recall, customers may contact Sedgwick, the company managing the recall notification process. The FDA recall number is D-0994-2022.
The recalled product
- Product
- MIOCHOL E (ACETYLCHOLINE CHLORIDE)
- Brand
- MIOCHOL E
- Manufacturer
- Mckesson Medical-Surgical Inc. Corporate Office
- Category
- Drug — Ophthalmic / Injectable
- Hazard
- temperature-abuse
- sterility-compromise
Distribution
Distributed nationwide across the United States.
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