Agency classClass IIOur severity:High FDA (Drugs)·D-1058-2022·Announced 2022-06-15

Sodium Bicarbonate Antacid Tablets Recalled for Manufacturing Temperature Abuse

McKesson Medical-Surgical is recalling Sodium Bicarbonate Antacid Tablets nationwide due to temperature abuse during manufacturing. Consumers should consult their healthcare provider about continued use.

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 recall involving a current Good Manufacturing Practice (cGMP) violation with temperature abuse of medication. No illnesses, injuries, or deaths have been reported. Per the severity rubric, a risk-of-harm product where injury has not been reported scores as High (3).

Plain-English summary

McKesson Medical-Surgical Inc. is recalling Sodium Bicarbonate Antacid Tablets (600 mg, 1000-count bottles) distributed nationwide. The recall affects products manufactured by Rugby Laboratories under National Drug Code 0536-1047-10.

The recall is issued due to current Good Manufacturing Practice (cGMP) deviations related to temperature abuse during manufacturing or distribution. Temperature exposure can affect the stability and quality of pharmaceutical products. McKesson Medical-Surgical was unable to identify specific lot numbers that may have been affected, as records do not clearly indicate which lots reached individual customers.

Persons currently taking this product should consult their healthcare provider or pharmacist to determine whether they should continue use or seek a replacement product. Consumers should not discard medication without consulting their healthcare provider, but should ask about proper disposal of the recalled product or obtaining an alternative.

The recalled product

Product: SODIUM BICARBONATE ANTACID (SODIUM BICARBONATE)
Brand: SODIUM BICARBONATE ANTACID
Manufacturer: Mckesson Medical-Surgical Inc. Corporate Office
Category: Drug — Antacid / OTC
Hazard: cgmp-deviation
temperature-abuse

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

UPCs (1)

0305361047108

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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