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.
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 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.
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