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Class II: temporary or reversible health riskTerminated

Mylan Pharmaceuticals Loxapine Capsules Recall

Loxapine Capsules, USP 50 mg, Rx Only, 100-count bottles

Mylan Pharmaceuticals Inc. · Morgantown, WV

Risk level
Class II
Reported by FDA
May 30, 2018
Recall ID
D-0825-2018
Check your lot numberHow we source this data

Summary

Mylan Pharmaceuticals recalled Loxapine Capsules starting Apr 24, 2018. The FDA classified it as Class II (temporary or reversible health risk) and published enforcement report D-0825-2018 on May 30, 2018. Reason: CGMP Deviations. Status: Terminated.

Why it was recalled

CGMP Deviations

Product description

Loxapine Capsules, USP 50 mg, Rx Only, 100-count bottles, NDC 0378-7050-01

Lot numbers, UPCs & expiration codes

NDC 0378-7050-01 Lot Numbers: 3079386, Exp. 10/31/18 3079387, Exp. 10/31/18 3079388, Exp. 10/31/18 3083762, Exp. 3/31/19 3083763, Exp. 3/31/19 3083764, Exp. 3/31/19 3083765, Exp. 3/31/19 3083766, Exp. 3/31/19 3083767, Exp. 3/31/19

Where it was sold

Product was distributed throughout the United States, including 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-0825-2018
Classification
Class II
Status
Terminated
Recall initiated
Apr 24, 2018
FDA report date
May 30, 2018
Quantity
11,650 bottles
Recall type
Voluntary: Firm initiated
Recalling firm
Mylan Pharmaceuticals Inc.

Original FDA data

Every field from FDA enforcement report D-0825-2018, exactly as published.

Show all FDA fields
City
Morgantown
State
WV
Status
Terminated
Country
United States
Event ID
79955
Address
781 Chestnut Ridge Rd
Code information
NDC 0378-7050-01 Lot Numbers: 3079386, Exp. 10/31/18 3079387, Exp. 10/31/18 3079388, Exp. 10/31/18 3083762, Exp. 3/31/19 3083763, Exp. 3/31/19 3083764, Exp. 3/31/19 3083765, Exp. 3/31/19 3083766, Exp. 3/31/19 3083767, Exp. 3/31/19
Postal code
26505-2730
Report date
May 30, 2018
Product type
Drugs
Recall number
D-0825-2018
Classification
Class II
Recalling firm
Mylan Pharmaceuticals Inc.
Product quantity
11,650 bottles
Termination date
Aug 14, 2019
Reason for recall
CGMP Deviations
Voluntary / mandated
Voluntary: Firm initiated
Product description
Loxapine Capsules, USP 50 mg, Rx Only, 100-count bottles, NDC 0378-7050-01
Distribution pattern
Product was distributed throughout the United States, including Puerto Rico.
Recall initiation date
Apr 24, 2018
Initial firm notification
Letter
Center classification date
May 22, 2018

How we source this data

Source: U.S. Food and Drug Administration enforcement report D-0825-2018, published May 30, 2018. 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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