The Recall Desk
HighFDA (Drugs)·D-0461-2023·Announced 2023-03-22

Alprazolam Tablets Recalled for Potential Cross-Contamination from Manufacturing Deviations

Breckenridge Pharmaceuticals is recalling Alprazolam 2 mg tablets nationwide due to manufacturing practice deviations creating potential cross-contamination risk. Affected tablets are distributed in 100-count and 500-count bottles.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: This is an FDA Class II recall involving potential cross-contamination at a pharmaceutical manufacturing facility due to CGMP deviations. While no illnesses or injuries have been reported in the source, cross-contamination of controlled medications presents a significant risk of harm, meeting the rubric criterion for 'risk-of-harm products where injury has not yet been reported.'

Plain-English summary

Breckenridge Pharmaceuticals is recalling multiple lots of Alprazolam Tablets, USP, 2 mg due to Current Good Manufacturing Practice (CGMP) deviations that present a potential risk of cross-contamination. The affected product is manufactured by Centaur Pharmaceuticals in India.

The recalled tablets are supplied in 100-count bottles (NDC 51991-0707-01) and 500-count bottles (NDC 51991-0707-05). Affected lot numbers have expiration dates ranging from March 31, 2023, through August 31, 2024. The product was distributed nationwide throughout the United States.

The specific affected lot numbers can be found in the official FDA recall announcement (Recall #D-0461-2023) or by contacting Breckenridge Pharmaceuticals directly. Patients or healthcare providers with questions or who have affected medication should contact their pharmacy or the manufacturer.

The recalled product

Product
Alprazolam Tablets, USP, 2 mg, CIV, packaged in: a)100-count bottle (NDC 51991-0707-01) and b) 500-count bottle (NDC 51991-0707-05), Rx only, Manufactured by Centaur Pharmaceuticals PVT. LTD., Hinjewadi, Pune, INDIA, Distributed by: Breckenridge Pharmaceuticals, Inc., Berlin, CT
Manufacturer
Breckenridge Pharmaceutical, Inc
Category
Drug
Hazard
  • cross-contamination
  • manufacturing-defect

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 (20)

  • Lot # 5210546
  • exp. date 3/31/2023
  • 100's Bottle 5210547
  • 500's Bottle 5210548
  • 500's Bottle 5210642
  • 100's Bottle 5210643
  • 100's Bottle 5210644
  • 500's Bottle 5210766
  • exp. date 4/30/2023
  • 100's Bottle 5210767
  • 100's Bottle 5210768
  • 500's Bottle 5210999
  • exp. date 5/31/2023
  • 500's Bottle 5211000
  • 500's Bottle 5211001
  • 500's Bottle 5211002
  • 500's Bottle 5211003
  • 500's Bottle 5211004
  • exp. date 6/30/2023
  • 500's Bottle 5211005

Distribution

Distributed nationwide across the United States.

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