Adalat CC Tablets Recalled for Sorafenib Cross-Contamination
Alvogen, Inc. is recalling Adalat CC (nifedipine) Extended Release Tablets 30 mg 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 agency classified this as an FDA Class III recall, which is defined as unlikely to cause adverse health consequences. The hazard is a voluntary precautionary recall for cross-contamination without reported injuries.
Plain-English summary
Alvogen, Inc. is voluntarily recalling Adalat CC (nifedipine) Extended Release Tablets 30 mg, 100-count bottles, NDC 50419-701-05. The recall is limited to Lot # BXH1P21A with an expiration date of 11/2017. The product was distributed nationwide.
The recall was initiated because residual powder identified as sorafenib was found in the inlet air duct, indicating cross-contamination with another product. Sorafenib is a different medication, and its presence in nifedipine tablets poses a risk of unintended exposure.
Patients and healthcare providers should stop using the affected lot and contact their healthcare provider for guidance. Consumers should check their medication bottles for the specific lot number and expiration date listed above.
The recalled product
- Product
- Adalat CC (nifedipine) Extended Release Tablets 30 mg, 100-count bottles, Rx only, Manufactured for Bayer Healthcare Bayer Healthcare Pharmaceuticals Inc. Whippany, NJ 07901 Manufactured in Germany, NDC 50419-701-05
- 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 #: BXH1P21A
- Exp. 11/2017
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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