Alvogen Recalls Adalat CC Tablets Due to Sorafenib Cross-Contamination
Alvogen, Inc. is recalling specific lots of Adalat CC (nifedipine) Extended-Release Tablets due to cross-contamination with sorafenib powder.
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 FDA classified this as a Class III recall, which is typically associated with low risk of adverse health consequences, fitting the Moderate severity criteria for minor labeling or low-risk contamination issues.
Plain-English summary
Alvogen, Inc. is recalling Adalat CC (nifedipine) Extended-Release Tablets, 90 mg, 100-count bottles. The recall involves Lot # BXH66D1A with an expiration date of 03/2018. The product is distributed nationwide and is manufactured for Almatica Pharma Inc.
The recall was initiated because residual powder was found in the inlet air duct that was identified as sorafenib. This indicates cross-contamination with another product. The FDA has classified this recall as Class III.
Consumers should check their medication for the specific lot number and expiration date listed above. If the product matches the recalled lot, they should contact their healthcare provider or pharmacist for guidance on next steps.
The recalled product
- Product
- Adalat CC (nifedipine) Extended-Release Tablets, 90 mg, 100-count bottles, Rx Only, Manufactured for Almatica Pharma Inc. Pine Brook, NJ 07058 USA, NDC 50419-70305
- Manufacturer
- Alvogen, Inc
- Category
- Drug — Prescription Medication
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 (2)
- Lot #: BXH66D1A
- Exp. 03/2018
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 9 recalled by Alvogen, Inc 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.
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