Pilocarpine Ophthalmic Solution Recalled Due to Temperature Abuse During Manufacturing
McKesson Medical-Surgical Inc. is recalling Pilocarpine HCL Ophthalmic Solution due to temperature abuse during manufacturing that may affect product stability. The product was distributed nationwide.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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: This is an FDA Class II pharmaceutical recall due to temperature control failures during manufacturing that may compromise product quality or potency. No illnesses or injuries have been reported, making this a theoretical risk-of-harm situation that qualifies as 'High' per the rubric.
Plain-English summary
McKesson Medical-Surgical Inc. is recalling Pilocarpine HCL Ophthalmic Solution, USP 2%, 15 mL, manufactured by Somerset Therapeutics, Inc. (NDC 7006919101). Pilocarpine is an ophthalmic medication used for prescription treatment.
The recall is due to cGMP (current Good Manufacturing Practice) deviations involving temperature abuse during manufacturing. Temperature control failures may affect the product's stability, potency, or efficacy.
The product was distributed nationwide. The manufacturer is unable to identify which specific lot numbers were received by individual customers. Instead, each customer letter includes the date the product was distributed to them and the dates when impacted product may have been shipped to their location.
Customers who have received this product should contact McKesson Medical-Surgical Inc. or consult their healthcare provider for guidance regarding the recalled medication.
The recalled product
- Product
- Pilocarpine HCL Ophthalmic Solution, USP 2%, 15 mL, Rx only, MFG: Somerset Therapeutics, Inc., NDC 7006919101
- Manufacturer
- Mckesson Medical-Surgical Inc. Corporate Office
- Affected units
- 1
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.
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