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Class II: temporary or reversible health riskTerminated

Mylan Pharmaceuticals Alprazolam Tablets Recall

Alprazolam Tablets, USP 0

Mylan Pharmaceuticals Inc. · Morgantown, WV

Risk level
Class II
Reported by FDA
Nov 13, 2019
Recall ID
D-0186-2020
Check your lot numberHow we source this data

Summary

Mylan Pharmaceuticals recalled Alprazolam Tablets starting Oct 23, 2019. The FDA classified it as Class II (temporary or reversible health risk) and published enforcement report D-0186-2020 on Nov 13, 2019. Reason: Presence of Foreign Substance. Status: Terminated.

Why it was recalled

Presence of Foreign Substance

Product description

Alprazolam Tablets, USP 0.5 mg, 500-count bottles, Rx only, Manufactured for: Mylan Pharmaceuticals Inc. Morgantown, WV 26505 Made in Australia, NDC 0378-4003-05

Lot numbers, UPCs & expiration codes

Lot #: 8082708, Exp. Date September 2020

Where it was sold

Nationwide within the United States

What to do if you have this product

  • Compare the lot number and expiration date on your package with the codes above.
  • Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
  • If you have symptoms you think are related, contact your doctor. In an emergency call 911.
  • Report side effects to FDA MedWatch at 1-800-FDA-1088.

Recall details

Recall number
D-0186-2020
Classification
Class II
Status
Terminated
Recall initiated
Oct 23, 2019
FDA report date
Nov 13, 2019
Quantity
5,760 bottles
Recall type
Voluntary: Firm initiated
Recalling firm
Mylan Pharmaceuticals Inc.

Original FDA data

Every field from FDA enforcement report D-0186-2020, exactly as published.

Show all FDA fields
City
Morgantown
State
WV
Status
Terminated
Country
United States
Event ID
84080
Address
781 Chestnut Ridge Rd
Code information
Lot #: 8082708, Exp. Date September 2020
Postal code
26505-2730
Report date
Nov 13, 2019
Product type
Drugs
Recall number
D-0186-2020
Classification
Class II
Recalling firm
Mylan Pharmaceuticals Inc.
Product quantity
5,760 bottles
Termination date
Dec 10, 2020
Reason for recall
Presence of Foreign Substance
Voluntary / mandated
Voluntary: Firm initiated
Product description
Alprazolam Tablets, USP 0.5 mg, 500-count bottles, Rx only, Manufactured for: Mylan Pharmaceuticals Inc. Morgantown, WV 26505 Made in Australia, NDC 0378-4003-05
Distribution pattern
Nationwide within the United States
Recall initiation date
Oct 23, 2019
Initial firm notification
Letter
Center classification date
Nov 5, 2019

How we source this data

Source: U.S. Food and Drug Administration enforcement report D-0186-2020, published Nov 13, 2019. View the source record (openFDA) · FDA enforcement reports

Last checked against FDA data: . Content last changed: .

FindMyRecall is an independent service and is not affiliated with or endorsed by the FDA. This page simplifies the official record; the FDA or manufacturer notice is authoritative, so follow its instructions. Medication information here is not individualized medical advice.

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