Loperamide Hydrochloride Capsules Recalled Nationwide for Manufacturing Temperature Deviation
McKesson is recalling Loperamide Hydrochloride 2 mg capsules nationwide due to cGMP deviations involving temperature abuse during manufacturing that may affect medication stability.
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: This FDA Class II recall involves cGMP deviations with temperature abuse during manufacturing, which may compromise medication stability and efficacy. No illnesses or injuries have been reported; this qualifies as a risk-of-harm product where injury has not yet been reported.
Plain-English summary
McKesson Medical-Surgical Inc. is recalling Loperamide Hydrochloride capsules, USP, 2 mg, in 100-count bottles (NDC 0378-2100-01), manufactured by Mylan Pharmaceuticals Inc. The product is distributed nationwide in the United States.
The recall was initiated due to current Good Manufacturing Practice (cGMP) deviations during manufacturing. The specific deviation involved temperature abuse, which may compromise the stability and quality of the medication.
Patients who have this medication should stop using it and contact their healthcare provider or pharmacist for guidance on obtaining a replacement supply or alternative medication. Healthcare providers should assess whether patients need immediate action based on individual medical circumstances.
McKesson is unable to identify the specific lot number received by individual customers. Affected customers have been notified with the distribution dates and the timeframe during which product may have been shipped to them.
The recalled product
- Product
- LOPERAMIDE HYDROCHLORIDE (LOPERAMIDE HYDROCHLORIDE)
- Brand
- LOPERAMIDE HYDROCHLORIDE
- Manufacturer
- Mckesson Medical-Surgical Inc. Corporate Office
- Category
- Drug — Prescription Medication
- Hazard
- temperature-abuse
- manufacturing-defect
- stability-risk
Distribution
Distributed nationwide across the United States.
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