Pfizer Recalls Norpace CR Capsules for Failed Dissolution Specification
Pfizer is recalling specific lots of Norpace CR (disopyramide phosphate) capsules because they failed to meet dissolution specifications.
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 1/5 (Low).
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: The FDA classified this as a Class III recall, which indicates that the violation is not likely to cause adverse health consequences. The hazard is a quality control issue (dissolution) without reported injuries.
Plain-English summary
Pfizer Inc is voluntarily recalling 5,410 bottles of Norpace CR (disopyramide phosphate) extended-release capsules, 150 mg. The affected products are packaged in 100-count bottles (NDC 0025-2742-31) and 500-count bottles (NDC 0025-2742-51). The recall involves Lot C120138 and Lot C120137, both with an expiration date of 07/13.
The recall was initiated because the product failed to meet dissolution specifications. Dissolution testing ensures that the medication releases the active ingredient at the correct rate; failure to meet these specifications may result in the drug not being absorbed as intended.
The affected products were distributed nationwide and in Puerto Rico. Consumers and healthcare providers should check their inventory for the specific lot numbers and expiration dates listed above. If the product is found, it should be returned to the pharmacy or point of purchase for a refund or replacement.
The recalled product
- Product
- NORPACE CR (DISOPYRAMIDE PHOSPHATE)
- Brand
- NORPACE CR
- Manufacturer
- Pfizer Inc
- Category
- Drug — Prescription Drug
- Hazard
- Affected units
- 5,410
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 #: a) C120138
- Exp 07/13
- b) C120137
UPCs (4)
- 0300252752314
- 0300252762313
- 0300252742315
- 0300252732316
Distribution
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