The Recall Desk
Agency classClass IIIOur severity:LowFDA (Drugs)·D-0630-2017·Announced 2017-04-12

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

Alvogen, Inc. is recalling Nifedipine Extended-Release Tablets, 60 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 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 the product is unlikely to cause adverse health consequences, aligning with the 'Low' severity criteria for documentation or minor issues.

Plain-English summary

Alvogen, Inc. is recalling Nifedipine Extended-Release Tablets, 60 mg, 100-count bottles (NDC 47781-369-01). The recall was initiated because residual powder from another product, identified as sorafenib, was found in the inlet air duct of the manufacturing facility. This indicates potential cross-contamination of the nifedipine tablets.

The affected lots include BXH1P41, BXH1BEE1, BXH1BE2, BXH1BE1B, BXH1BE1A, and BXH1P41A with an expiration date of 01/2018; BXH81R1, BXHBD41A, BXH5ZR1, and BXH9AL1A with an expiration date of 06/2018; and BXHCUD1A and BXHCUF2A with an expiration date of 01/2019. The products were distributed nationwide.

The U.S. Food and Drug Administration has classified this recall as Class III, which means the product is not likely to cause adverse health consequences. Consumers and healthcare providers should check their inventory for these specific lot numbers and expiration dates. If found, the medication should be returned to the pharmacy or point of purchase for disposal or replacement.

The recalled product

Product
Nifedipine Extended-Release Tablets, 60 mg, 100-count bottles, Rx Only, Manufactured for Alvogen Inc. Pine Brook, NJ 07058 USA, NDC 47781-369-01.
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 #: BXH1P41
  • BXH1BEE1
  • BXH1BE2
  • BXH1BE1B
  • BXH1BE1A
  • BXH1P41A
  • Exp. 01/2018
  • BXH81R1
  • BXHBD41A
  • BXH5ZR1
  • BXH9AL1A
  • Exp. 06/2018
  • BXHCUD1A
  • BXHCUF2A
  • 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.

See all 9 products in this recall →

Related recalls

Same manufacturer · Alvogen, Inc

See all →

Same hazard · cross contamination

See all →

Similar recalls