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
- Affected units
- 45
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 130 recalled by Mckesson Medical-Surgical Inc. Corporate Office 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 130 products in this recall →Related recalls
Same manufacturer · Mckesson Medical-Surgical Inc. Corporate Office
See all →- ModerateStrep A test kits recalled after shipment to unlicensed purchasing customers
FDA (Devices) · 2025-08-27
- ModerateProlia prefilled syringes recalled after potential temperature excursions during transit delays
FDA (Drugs) · 2025-07-30
- ModerateEvenity prefilled syringes recalled after potential temperature excursions during transit delays
FDA (Drugs) · 2025-07-30
- ModerateBenlysta vials recalled after potential temperature excursions during transit delays
FDA (Drugs) · 2025-07-30
- ModerateAbbott Diagnostics ARC Carbon Dioxide Calibrator Cold Chain Storage Issue
FDA (Devices) · 2025-06-04
Same hazard · temperature abuse
See all →- ModerateGemcitabine Injection Recalled Due to Temperature Storage Abuse
FDA (Drugs) · 2026-07-08
- ModerateGarland Fresh peeled garlic recalled over Clostridium botulinum contamination risk
FDA (Food) · 2026-05-13
- ModerateChristopher Ranch peeled garlic recalled over Clostridium botulinum contamination risk
FDA (Food) · 2026-05-13
- SevereCrab Cakes Sold to Food Service Recalled for Botulism Risk
FDA (Food) · 2026-04-15
- CriticalUDENYCA syringes recalled after cartons were stored at room temperature
FDA (Drugs) · 2026-02-18