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Class II: temporary or reversible health riskTerminated

Mylan Pharmaceuticals Mirtazapine Tablets Recall

Mirtazapine Tablets, USP 45 mg, a) 30 count, b) 100 count and c) 500 count bottles, Rx…

Mylan Pharmaceuticals Inc. · Morgantown, WV

Risk level
Class II
Reported by FDA
Mar 15, 2017
Recall ID
D-0492-2017
Check your lot numberHow we source this data

Summary

Mylan Pharmaceuticals recalled Mirtazapine Tablets starting Jan 19, 2017. The FDA classified it as Class II (temporary or reversible health risk) and published enforcement report D-0492-2017 on Mar 15, 2017. Reason: Presence of Foreign Tablets/Capsules; possibility of Glipizide 10 mg tablet in bottle. Status: Terminated.

Why it was recalled

Presence of Foreign Tablets/Capsules; possibility of Glipizide 10 mg tablet in bottle

Product description

Mirtazapine Tablets, USP 45 mg, a) 30 count, b) 100 count and c) 500 count bottles, Rx only, Mylan Pharmaceuticals Inc., Morgantown, WV

Lot numbers, UPCs & expiration codes

a) 3078937 and 3078938 (NDC 0378-3545-93), exp August 2019 b) 3078937 (NDC 0378-3545-01), exp August 2019 c) 3078936 (0378-3545-05), exp August 2019

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-0492-2017
Classification
Class II
Status
Terminated
Recall initiated
Jan 19, 2017
FDA report date
Mar 15, 2017
Quantity
37,445 bottles
Recall type
Voluntary: Firm initiated
Recalling firm
Mylan Pharmaceuticals Inc.

Original FDA data

Every field from FDA enforcement report D-0492-2017, exactly as published.

Show all FDA fields
City
Morgantown
State
WV
Status
Terminated
Country
United States
Event ID
76357
Address
781 Chestnut Ridge Rd
Code information
a) 3078937 and 3078938 (NDC 0378-3545-93), exp August 2019 b) 3078937 (NDC 0378-3545-01), exp August 2019 c) 3078936 (0378-3545-05), exp August 2019
Postal code
26505-2730
Report date
Mar 15, 2017
Product type
Drugs
Recall number
D-0492-2017
Classification
Class II
Recalling firm
Mylan Pharmaceuticals Inc.
Product quantity
37,445 bottles
Termination date
Jul 12, 2017
Reason for recall
Presence of Foreign Tablets/Capsules; possibility of Glipizide 10 mg tablet in bottle
Voluntary / mandated
Voluntary: Firm initiated
Product description
Mirtazapine Tablets, USP 45 mg, a) 30 count, b) 100 count and c) 500 count bottles, Rx only, Mylan Pharmaceuticals Inc., Morgantown, WV
Distribution pattern
Nationwide
Recall initiation date
Jan 19, 2017
Initial firm notification
E-Mail
Center classification date
Mar 8, 2017

How we source this data

Source: U.S. Food and Drug Administration enforcement report D-0492-2017, 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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