Pantoprazole Sodium Injection 40 mg Recalled Due to Manufacturing Procedure Deviation
Methapharm Inc is recalling Pantoprazole Sodium 40 mg injection vials due to a manufacturing procedure deviation. Affected products were inadvertently placed into distribution without proper compliance with approved procedures.
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: This is an FDA Class II recall, but no specific contamination, defect, or reported illnesses/injuries are documented. The hazard is a manufacturing procedure deviation that is theoretical rather than confirmed. Per the rubric, when no illnesses/injuries are reported and the hazard is theoretical, the score is at most 3. The procedural nature and absence of identified product defects support a score of 2 (Moderate).
Plain-English summary
Methapharm Inc is recalling Pantoprazole Sodium for Injection 40 mg/vial (NDC 67850-150-10 and 67850-150-00) distributed nationwide in the USA. The recall affects 5,377 cartons with lot numbers 220801, 220802, and 220803, all with expiration dates of July 2024.
The recall was initiated due to a Current Good Manufacturing Practice (CGMP) deviation. Affected product was inadvertently placed into saleable inventory in a manner that did not comply with approved manufacturing procedures. No specific product defect or identified safety hazard is described in the recall notice.
Healthcare providers should identify the lot numbers of their Pantoprazole Sodium inventory and contact their suppliers for specific guidance regarding this recall.
The recalled product
- Product
- Pantoprazole sodium for Injection 40 mg*/vial, Single-dose Vial, Rx only, For Intravenous Infusion Only, Mfd. for Methapharm, Inc. Coral Springs, FL, 33065, NDC 67850-150-10 (carton), NDC 67850-150-00 (vial).
- Manufacturer
- Methapharm Inc
- Category
- Drug — Injectable
- Hazard
- Affected units
- 5,377
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (3)
- Lots: 220801
- 220802
- 220803 Exp. July 2024
Distribution
Distributed nationwide across the United States.
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