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Class III: unlikely to cause harmTerminated

Aurobindo Pharma Olanzapine Tablets Recall

Olanzapine Tablets, USP 2

Aurobindo Pharma USA Inc. · East Windsor, NJ

Risk level
Class III
Reported by FDA
Jun 24, 2020
Recall ID
D-1314-2020
Check your lot numberHow we source this data

Summary

Aurobindo Pharma recalled Olanzapine Tablets starting May 26, 2020. The FDA classified it as Class III (unlikely to cause harm) and published enforcement report D-1314-2020 on Jun 24, 2020. Reason: Failed Impurities/ Degradation Specifications. Status: Terminated.

Why it was recalled

Failed Impurities/ Degradation Specifications

Product description

Olanzapine Tablets, USP 2.5 mg, 30-count bottle, Rx only, Manufactured for: Prasco Laboratories Mason, OH 45040 USA, Manufactured by: Aurolife Pharma LLC Dayton, NJ 08810, NDC 66993-680-30

Lot numbers, UPCs & expiration codes

Lot #: 561180046A1, Exp 8/2020

Where it was sold

U.S.A. 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-1314-2020
Classification
Class III
Status
Terminated
Recall initiated
May 26, 2020
FDA report date
Jun 24, 2020
Quantity
13322 bottles
Recall type
Voluntary: Firm initiated
Recalling firm
Aurobindo Pharma USA Inc.

Original FDA data

Every field from FDA enforcement report D-1314-2020, exactly as published.

Show all FDA fields
City
East Windsor
State
NJ
Status
Terminated
Country
United States
Event ID
85756
Address
279 Princeton Hightstown Rd
Code information
Lot #: 561180046A1, Exp 8/2020
Postal code
08520-1401
Report date
Jun 24, 2020
Product type
Drugs
Recall number
D-1314-2020
Classification
Class III
Recalling firm
Aurobindo Pharma USA Inc.
Product quantity
13322 bottles
Termination date
Jan 10, 2023
Reason for recall
Failed Impurities/ Degradation Specifications
Voluntary / mandated
Voluntary: Firm initiated
Product description
Olanzapine Tablets, USP 2.5 mg, 30-count bottle, Rx only, Manufactured for: Prasco Laboratories Mason, OH 45040 USA, Manufactured by: Aurolife Pharma LLC Dayton, NJ 08810, NDC 66993-680-30
Distribution pattern
U.S.A. Nationwide
Recall initiation date
May 26, 2020
Initial firm notification
Letter
Center classification date
Jun 17, 2020

How we source this data

Source: U.S. Food and Drug Administration enforcement report D-1314-2020, published Jun 24, 2020. 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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