The Recall Desk
HighFDA (Drugs)·D-0460-2023·Announced 2023-03-22

Alprazolam Tablets Recalled for Potential Cross-Contamination from Manufacturing Deviations

Breckenridge Pharmaceutical is recalling Alprazolam 1 mg tablets distributed nationwide due to manufacturing practice deviations that pose a potential cross-contamination risk.

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 for manufacturing practice deviations creating a potential cross-contamination risk in a controlled benzodiazepine. No illnesses or injuries are reported in the source, and the hazard is theoretical, capping the score at 3 per the rubric. However, Alprazolam is a risk-of-harm product where potential cross-contamination justifies a High severity rating.

Plain-English summary

Breckenridge Pharmaceutical, Inc. is recalling multiple lots of Alprazolam Tablets, USP, 1 mg distributed nationwide in the United States. The affected lots are available in 100-count, 500-count, and 1,000-count bottles, manufactured by Centaur Pharmaceuticals PVT. LTD. and identified by specific lot numbers with expiration dates through February 2025.

The recall was initiated due to current good manufacturing practice (CGMP) deviations. These deviations created a potential risk of cross-contamination.

Patients currently taking Alprazolam should contact their pharmacy or healthcare provider to confirm whether their medication is included in the recall. Do not discontinue Alprazolam without medical guidance. Affected lot numbers and expiration dates should be verified through the recalling firm or the FDA's drug recall database.

Healthcare providers and pharmacies should immediately discontinue dispensing affected lots and check their medication inventory.

The recalled product

Product
Alprazolam Tablets, USP, 1 mg, CIV, packaged in: a) 100-count bottle (NDC 51991-0706-01), b) 500-count bottle (NDC 51991-0706-05) and c) 1,000-count bottle (NDC 51991-0706-10), Rx only, Manufactured by Centaur Pharmaceuticals PVT. LTD., Hinjewadi, Pune, INDIA, Distributed by: Bre
Manufacturer
Breckenridge Pharmaceutical, Inc
Category
Drug
Hazard
  • cross-contamination
  • cgmp-deviation

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 # 5210645
  • exp. date 3/31/2023
  • 500's Bottle 5210646
  • 500's Bottle 5210647
  • 500's Bottle 5210648
  • 1000's Bottle 5210649
  • 1000's Bottle 5210831
  • exp. date 4/30/2023
  • 100's Bottle 5210832
  • 500's Bottle 5210833
  • 500's Bottle 5210834
  • 1000's Bottle 5210835
  • 1000's Bottle 5210905
  • exp. date 5/31/2023
  • 100's Bottle 5210906
  • 100's Bottle 5210907
  • 500's Bottle 5210908
  • 500's Bottle 5210909
  • 500's Bottle 5210965
  • 500's Bottle 5210997

Distribution

Distributed nationwide across the United States.

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