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Class II: temporary or reversible health riskTerminated

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

Mirtazapine Tablets, USP, 45 mg

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

Risk level
Class II
Reported by FDA
Mar 15, 2017
Recall ID
D-0493-2017
Check your lot numberHow we source this data

Summary

Mylan Institutional, Inc. (d.b.a. UDL Laboratories) recalled Mirtazapine Tablets starting Jan 27, 2017. The FDA classified it as Class II (temporary or reversible health risk) and published enforcement report D-0493-2017 on Mar 15, 2017. Reason: Presence of Foreign Tablets/Capsules; possibility of Glipizide 10 mg tablets commingled. Status: Terminated.

Why it was recalled

Presence of Foreign Tablets/Capsules; possibility of Glipizide 10 mg tablets commingled

Product description

Mirtazapine Tablets, USP, 45 mg. Rx only, 100 Tablets (10 X 10). Manufactured by: Mylan Pharmaceuticals Inc, Morgantown, WV ---NDC 51079-088-20

Lot numbers, UPCs & expiration codes

Batch #3083289; Exp. Date 12/2018

Where it was sold

Nationwide

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-0493-2017
Classification
Class II
Status
Terminated
Recall initiated
Jan 27, 2017
FDA report date
Mar 15, 2017
Quantity
58 UD100 Unit Dose Blister Cards of 10 (10 cards of 10 tablets each)
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-0493-2017, exactly as published.

Show all FDA fields
City
Rockford
State
IL
Status
Terminated
Country
United States
Event ID
76463
Address
1718 Northrock Ct
Code information
Batch #3083289; Exp. Date 12/2018
Postal code
61103-1201
Report date
Mar 15, 2017
Product type
Drugs
Recall number
D-0493-2017
Classification
Class II
Recalling firm
Mylan Institutional, Inc. (d.b.a. UDL Laboratories)
Product quantity
58 UD100 Unit Dose Blister Cards of 10 (10 cards of 10 tablets each)
Termination date
Mar 15, 2019
Reason for recall
Presence of Foreign Tablets/Capsules; possibility of Glipizide 10 mg tablets commingled
Voluntary / mandated
Voluntary: Firm initiated
Product description
Mirtazapine Tablets, USP, 45 mg. Rx only, 100 Tablets (10 X 10). Manufactured by: Mylan Pharmaceuticals Inc, Morgantown, WV ---NDC 51079-088-20
Distribution pattern
Nationwide
Recall initiation date
Jan 27, 2017
Initial firm notification
Letter
Center classification date
Mar 8, 2017

How we source this data

Source: U.S. Food and Drug Administration enforcement report D-0493-2017, published Mar 15, 2017. 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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