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Class II: temporary or reversible health riskTerminated

Mylan Institutional, Inc. (d.b.a. UDL Laboratories) Alprazolam Tablets Recall

Alprazolam Tablets, USP, 0

Mylan Institutional, Inc. (d.b.a. UDL Laboratories) · Rockford, IL

Risk level
Class II
Reported by FDA
Mar 27, 2019
Recall ID
D-1013-2019
Check your lot numberHow we source this data

Summary

Mylan Institutional, Inc. (d.b.a. UDL Laboratories) recalled Alprazolam Tablets starting Jan 18, 2019. The FDA classified it as Class II (temporary or reversible health risk) and published enforcement report D-1013-2019 on Mar 27, 2019. Reason: Failed Impurities/Degradation Specifications: Elevated levels of a known impurity detected during 6-month RT stability interval. Status: Terminated.

Why it was recalled

Failed Impurities/Degradation Specifications: Elevated levels of a known impurity detected during 6-month RT stability interval.

Product description

Alprazolam Tablets, USP, 0.25 mg, 10x10 per carton, Rx Only, Manufactured for: Mylan Pharmaceuticals Inc., Morgantown, WV 26505 USA. NDC: 51079-788-20

Lot numbers, UPCs & expiration codes

Lots: 3095198, 3096266, 3098776, EXP 05-2019

Where it was sold

Nationwide USA and Puerto Rico

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-1013-2019
Classification
Class II
Status
Terminated
Recall initiated
Jan 18, 2019
FDA report date
Mar 27, 2019
Quantity
10,281 UD cartons
Recall type
Voluntary: Firm initiated
Recalling firm
Mylan Institutional, Inc. (d.b.a. UDL Laboratories)

Original FDA data

Every field from FDA enforcement report D-1013-2019, exactly as published.

Show all FDA fields
City
Rockford
State
IL
Status
Terminated
Country
United States
Event ID
81946
Address
1718 Northrock Ct
Code information
Lots: 3095198, 3096266, 3098776, EXP 05-2019
Postal code
61103-1201
Report date
Mar 27, 2019
Product type
Drugs
Recall number
D-1013-2019
Classification
Class II
Recalling firm
Mylan Institutional, Inc. (d.b.a. UDL Laboratories)
Product quantity
10,281 UD cartons
Termination date
Apr 29, 2020
Reason for recall
Failed Impurities/Degradation Specifications: Elevated levels of a known impurity detected during 6-month RT stability interval.
Voluntary / mandated
Voluntary: Firm initiated
Product description
Alprazolam Tablets, USP, 0.25 mg, 10x10 per carton, Rx Only, Manufactured for: Mylan Pharmaceuticals Inc., Morgantown, WV 26505 USA. NDC: 51079-788-20
Distribution pattern
Nationwide USA and Puerto Rico
Recall initiation date
Jan 18, 2019
Initial firm notification
Letter
Center classification date
Mar 20, 2019

How we source this data

Source: U.S. Food and Drug Administration enforcement report D-1013-2019, published Mar 27, 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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