Alvogen Recalls Adalat CC Tablets Due to Sorafenib Cross-Contamination
Alvogen, Inc. is recalling Adalat CC (nifedipine) 90 mg extended-release tablets because residual sorafenib powder was found in the manufacturing equipment'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 recall is classified as FDA Class III, which indicates a low risk of adverse health consequences. The hazard is cross-contamination with sorafenib, but no illnesses or injuries are reported in the source text.
Plain-English summary
Alvogen, Inc. is recalling Adalat CC (nifedipine) Extended-Release Tablets, 90 mg, 100-count bottles. The recall is due to cross-contamination with another product, specifically residual powder identified as sorafenib found in the inlet air duct.
The affected product is identified by Lot # BXHD7U1A with an expiration date of 10/2018. The NDC number is 5242749601. The product was manufactured for Almatica Pharma Inc. and distributed nationwide.
Consumers and healthcare providers should check their inventory for this specific lot number and expiration date. If found, the product should be returned to the pharmacy or point of purchase for a refund or replacement, or disposed of according to local regulations. Patients should consult their healthcare provider for alternative treatment options if they have been using this specific lot.
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 5242749601
- 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 #: BXHD7U1A
- Exp. 10/2018
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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