Alvogen Recalls Adalat CC Tablets Due to Sorafenib Cross-Contamination
Alvogen 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 1/5 (Low).
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: The FDA classified this recall as Class III, which by definition indicates that use of or exposure to the violative product is not likely to cause adverse health consequences.
Plain-English summary
Alvogen, Inc. is recalling Adalat CC (nifedipine) Extended-Release Tablets, 30 mg, 100-count bottles. The recall affects Lot # BXHBJD1A with an expiration date of 10/2018. The product is distributed nationwide and is manufactured for Almatica Pharma Inc.
The recall was initiated due to cross-contamination with another product. Residual powder identified as sorafenib was found in the inlet air duct. Sorafenib is a different medication, and its presence in nifedipine tablets constitutes a contamination hazard.
Patients and healthcare providers should discontinue use of the affected lot and contact their healthcare provider for guidance. The FDA has classified this recall as Class III, indicating that use of or exposure to the violative product is not likely to cause adverse health consequences.
The recalled product
- Product
- Adalat CC (nifedipine) Extended-Release Tablets, 30 mg, 100-count bottles, Rx Only, Manufactured for Almatica Pharma Inc. Pine Brook, NJ 07058 USA, NDC 5242749401
- 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 #: BXHBJD1A
- 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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