Pfizer Recalls Norpace CR Capsules for Failed Dissolution Specification
Pfizer is recalling Norpace CR (disopyramide phosphate) capsules because they failed to meet dissolution specifications. The recall covers specific lots distributed nationwide.
The agency’s classification
FDA (Drugs): Class III
Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.
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: The recall is classified as FDA Class III, which indicates a low risk of adverse health consequences. The issue is a quality control failure (dissolution specification) rather than a direct safety hazard like contamination or mislabeling of a common allergen.
Plain-English summary
Pfizer Inc. is recalling Norpace CR (disopyramide phosphate) extended-release capsules, 150 mg, due to a failure to meet dissolution specifications. The affected product is packaged in 100-count bottles (NDC 0025-2742-31) and 500-count bottles (NDC 0025-2742-51). The recall includes 4,005 bottles of the 100-count size and 104 bottles of the 500-count size.
The affected lots are C150065 and C150064, with an expiration date of 6/16. The product was distributed nationwide. Norpace CR is a prescription-only medication used for the treatment of certain heart rhythm disorders.
Consumers and healthcare providers should check their inventory for the specific lot numbers and NDC codes listed above. If the product matches the recalled description, it should be returned to the pharmacy or distributor for a refund or replacement. Patients should consult their healthcare provider for alternative treatment options if necessary.
The recalled product
- Product
- NORPACE CR (DISOPYRAMIDE PHOSPHATE)
- Brand
- NORPACE CR
- Manufacturer
- Pfizer Inc.
- Category
- Drug — Prescription Drug
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)
- Lot #: C150065
- C150064
- Exp 6/16
UPCs (4)
- 0300252752314
- 0300252762313
- 0300252742315
- 0300252732316
Distribution
Distributed nationwide across the United States.
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