Agency classClass IIOur severity:Moderate FDA (Drugs)·D-1049-2022·Announced 2022-06-15

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.

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 2/5 (Moderate).

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
Category: Drug — Cardiac / Angina Medication
Hazard: cgmp-deviation
temperature-abuse

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 →

Same manufacturer · Mckesson Medical-Surgical Inc. Corporate Office

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