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.
What this means for you
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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