The Recall Desk
ModerateFDA (Drugs)·D-0629-2017·Announced 2017-04-12

Adalat CC Tablets Recalled for Sorafenib Cross-Contamination

Alvogen, Inc. is recalling Adalat CC (nifedipine) Extended Release Tablets due to cross-contamination with sorafenib powder found in the manufacturing facility.

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 recall is classified as FDA Class III, which indicates a remote possibility of adverse health consequences. The hazard is cross-contamination with sorafenib, a potent drug, but no illnesses or injuries are reported in the source text.

Plain-English summary

Alvogen, Inc. is recalling Adalat CC (nifedipine) Extended Release Tablets, 60 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 NDC 50419-702-05, manufactured for Almatica Pharma Inc. The specific lots involved are BXH1BE1A and BXH1P41A, both with an expiration date of 01/2018. The distribution pattern is listed as nationwide.

Consumers and healthcare providers should check their inventory for these specific lot numbers and expiration dates. 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 necessary.

The recalled product

Product
Adalat CC (nifedipine) Extended Release Tablets, 60 mg, 100- count bottles, Rx only Manufactured for Almatica, Almatica Pharma Inc. Pinebrook, NJ 07058 USA, NDC 50419-702-05
Manufacturer
Alvogen, Inc

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 (3)

  • Lot #: BXH1BE1A
  • BXH1P41A
  • Exp. 01/2018.

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.

See all 9 products in this recall →