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Class II: temporary or reversible health riskOngoing

AuroMedics Pharma Aurobindo Ranitidine Caspules 150 mg Recall

Aurobindo Ranitidine Caspules 150 mg, 60-count bottle, Rx Only Distributed by: Aurobind…

AuroMedics Pharma LLC · East Windsor, NJ

Risk level
Class II
Reported by FDA
Dec 4, 2019
Recall ID
D-0527-2020
Check your lot numberHow we source this data

Summary

AuroMedics Pharma recalled Aurobindo Ranitidine Caspules 150 mg starting Nov 6, 2019. The FDA classified it as Class II (temporary or reversible health risk) and published enforcement report D-0527-2020 on Dec 4, 2019. Reason: CGMP Deviations: N-nitrosodimethylamine (NDMA) has been detected in Ranitidine tablets, capsules and syrups. Status: Ongoing.

Why it was recalled

CGMP Deviations: N-nitrosodimethylamine (NDMA) has been detected in Ranitidine tablets, capsules and syrups.

Product description

Aurobindo Ranitidine Caspules 150 mg, 60-count bottle, Rx Only Distributed by: Aurobindo Pharma USA, Inc. 279 Princeton-Hightstown Road East Windsor, NJ 08520 NDC 59651-144-60

Lot numbers, UPCs & expiration codes

RA1518001-A Jul 2020 RA1518002-A Jul 2020 RA1518005-B Aug 2020 RA1518006-A Aug 2020 RA1519003-A May 2021

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-0527-2020
Classification
Class II
Status
Ongoing
Recall initiated
Nov 6, 2019
FDA report date
Dec 4, 2019
Quantity
45,456 bottles
Recall type
Voluntary: Firm initiated
Recalling firm
AuroMedics Pharma LLC

Original FDA data

Every field from FDA enforcement report D-0527-2020, exactly as published.

Show all FDA fields
City
East Windsor
State
NJ
Status
Ongoing
Country
United States
Event ID
84218
Address
279 Princeton Hightstown Rd
Code information
RA1518001-A Jul 2020 RA1518002-A Jul 2020 RA1518005-B Aug 2020 RA1518006-A Aug 2020 RA1519003-A May 2021
Postal code
08520-1401
Report date
Dec 4, 2019
Product type
Drugs
Recall number
D-0527-2020
Classification
Class II
Recalling firm
AuroMedics Pharma LLC
Product quantity
45,456 bottles
Reason for recall
CGMP Deviations: N-nitrosodimethylamine (NDMA) has been detected in Ranitidine tablets, capsules and syrups.
Voluntary / mandated
Voluntary: Firm initiated
Product description
Aurobindo Ranitidine Caspules 150 mg, 60-count bottle, Rx Only Distributed by: Aurobindo Pharma USA, Inc. 279 Princeton-Hightstown Road East Windsor, NJ 08520 NDC 59651-144-60
Distribution pattern
nationwide
Recall initiation date
Nov 6, 2019
Initial firm notification
Press Release
Center classification date
Nov 26, 2019

How we source this data

Source: U.S. Food and Drug Administration enforcement report D-0527-2020, published Dec 4, 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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