Miocol-E (acetylcholine chloride intraocular solution) 20 mg/2mL (10 mg/mL), Rx only, Manufacturer: Bausch & Lomb, NDC 24208-539-20
Check against the official notice below — it lists the full affected range.
Miocol-E (acetylcholine chloride intraocular solution) 20 mg/2mL, an injectable eye medication manufactured by Bausch & Lomb and distributed by McKesson Medical-Surgical Inc., has been recalled nationwide. The recall affects 45 kits due to current Good Manufacturing Practice (cGMP) deviations involving temperature abuse during storage or handling.
Because McKesson Medical-Surgical cannot identify specific lot numbers received by individual customers, the company has notified consignees that any product received between June 1 and September 30, 2021 may be affected. Affected customers should check their own records to determine whether they received impacted product during that timeframe and whether they still have any in inventory. The recall notification letter states that consignees may contact Sedgwick if they have questions, but the source does not specify what actions affected consumers should take with recalled product.
Written by software from the official notice below. Not reviewed by a lawyer.
cGMP deviations: Temperature abuse
Reason for recall: cGMP deviations: Temperature abuse Distribution: USA nationwide. Quantity: 45 kits 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. 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.
Official record: FDA (Drug enforcement) ↗
Republished from the official source above; details can change — the source record controls.