Alvogen Recalls Adalat CC Tablets Due to Sorafenib Cross-Contamination
Alvogen, Inc. is recalling Adalat CC (nifedipine) 60 mg extended-release tablets because residual sorafenib powder was found in the manufacturing facility's inlet air duct.
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 indicates a remote possibility of adverse health consequences. The hazard is cross-contamination with a different drug, but no illnesses or injuries are reported in the source text.
Plain-English summary
Alvogen, Inc. is voluntarily recalling Adalat CC (nifedipine) Extended-Release Tablets, 60 mg, 100-count bottles. The recall is limited to Lot # BXCUE1A with an expiration date of 01/2019. The product is distributed nationwide.
The recall was initiated due to cross-contamination with another product. Residual powder identified as sorafenib was found in the inlet air duct of the manufacturing facility. Sorafenib is a different medication, and its presence in the nifedipine tablets constitutes a contamination hazard.
Patients and healthcare providers should stop using the affected lot of Adalat CC and contact their healthcare provider for guidance on alternative treatment. The product is prescription-only, so consumers should not attempt to return it to retail pharmacies without professional instruction.
The recalled product
- Product
- Adalat CC (nifedipine) Extended-Release Tablets, 60 mg, 100-count bottles, Rx Only, Manufactured for Almatica Pharma Inc. Pine Brook, NJ 07058 USA, NDC 5242749501
- 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 #: BXCUE1A
- Exp. 01/2019
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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