The Recall Desk
Agency classClass IIIOur severity:ModerateFDA (Drugs)·D-0627-2017·Announced 2017-04-12

Alvogen Recalls Nifedipine Extended-Release Tablets Due to Sorafenib Cross-Contamination

Alvogen, Inc. is recalling Nifedipine Extended-Release Tablets, 30 mg, due to cross-contamination with sorafenib powder found in the manufacturing facility'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 FDA classified this as a Class III recall, which is defined as unlikely to cause adverse health consequences. The rubric maps Class III recalls to scores of 1 or 2; a score of 2 is appropriate for a cross-contamination issue involving a potent pharmaceutical agent, even if the immediate risk is low.

Plain-English summary

Alvogen, Inc. is recalling Nifedipine Extended-Release Tablets, 30 mg, 100-count bottles (NDC 47781-368-01). The recall is being conducted because residual powder identified as sorafenib was found in the inlet air duct of the manufacturing facility, indicating cross-contamination with another product.

The affected lots include BXH1P22, BXH1P21A, BXH1P21, BXH1P31, and BXH1P21B with expiration dates of 11/2017; BXH6EL1, BXH66A1, BXH6EN1, BXH6EP1, and BXH6ER1 with expiration dates of 06/2018; and BXH81K1A and BXHBJD1A with expiration dates of 10/2018. The products were distributed nationwide.

Consumers and healthcare providers should stop using the recalled products and contact their healthcare provider or pharmacist for guidance on alternative treatment options. 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
Nifedipine Extended-Release Tablets, 30 mg, 100-count bottles, Rx Only, Manufactured for Alvogen Inc. Pine Brook, NJ 07058 USA, NDC 47781-368-01.
Manufacturer
Alvogen, Inc
Category
Drug — Prescription Medication
Hazard

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 (15)

  • Lot #: BXH1P22
  • BXH1P21A
  • BXH1P21
  • BXH1P31
  • BXH1P21B
  • Exp. 11/2017
  • BXH6EL1
  • BXH66A1
  • BXH6EN1
  • BXH6EP1
  • BXH6ER1
  • Exp. 06/2018
  • BXH81K1A
  • 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.

See all 9 products in this recall →

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