Nitrostat Nitroglycerin Tablets Recalled Due to Temperature Abuse During Manufacturing
McKesson Medical-Surgical is recalling Nitrostat (nitroglycerin sublingual tablets) 0.4 mg due to manufacturing deviations involving temperature abuse that may affect product quality. The affected product was distributed nationwide.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: FDA Class II recall involving a manufacturing quality control issue with no reported illnesses or injuries. Temperature deviations during manufacturing may affect medication quality, but this represents a precautionary recall based on process compliance rather than confirmed product harm.
Plain-English summary
McKesson Medical-Surgical Inc. is recalling Nitrostat (nitroglycerin sublingual tablets, USP) 0.4 mg distributed by Pfizer Parke-Davis. The recall affects 25-count bottles with NDC 0071-0418-13.
The recall was initiated due to Current Good Manufacturing Practice (cGMP) deviations involving temperature abuse of the product during manufacturing. Temperature exposure may affect the stability and efficacy of the medication.
The affected product was distributed nationwide. Specific lot numbers could not be identified by the manufacturer; however, customers were notified with information about dates when affected product may have been shipped to them.
Patients should consult with their healthcare provider or pharmacist if they have this medication. Do not discontinue nitroglycerin therapy without consulting your healthcare provider. Contact your pharmacist to determine if you have affected product.
The recalled product
- Product
- Nitrostat (Nitroglycerin Sublingual Tablets, USP) 0.4 mg/tablet, 25-count bottle, Rx only, Distributed by: Pfizer Parke-Davis, Division of Pfizer Inc., NDC 0071-0418-13
- Manufacturer
- Mckesson Medical-Surgical Inc. Corporate Office
- Hazard
- cgmp-deviation
- temperature-abuse
Distribution
Distributed nationwide across the United States.
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