FindMyRecallSubscribe
Class II: temporary or reversible health riskTerminated

Novitium Pharma Ranitidine Capsules 300 mg Recall

Novitium Pharma Ranitidine Capsules 300 mg 100 capsules Rx Only Manufactured by: Noviti…

Novitium Pharma LLC · East Windsor, NJ

Risk level
Class II
Reported by FDA
Nov 20, 2019
Recall ID
D-0313-2020
Check your lot numberHow we source this data

Summary

Novitium Pharma recalled Novitium Pharma Ranitidine Capsules 300 mg starting Oct 25, 2019. The FDA classified it as Class II (temporary or reversible health risk) and published enforcement report D-0313-2020 on Nov 20, 2019. Reason: CGMP Deviations: Presence of NDMA impurity detected in product. Status: Terminated.

Why it was recalled

CGMP Deviations: Presence of NDMA impurity detected in product.

Product description

Novitium Pharma Ranitidine Capsules 300 mg 100 capsules Rx Only Manufactured by: Novitium Pharma LLC 70 Lake Drive, East Windsor, New Jersey 08520 NDC 70954-002-40

Lot numbers, UPCs & expiration codes

all lots within expiry.

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-0313-2020
Classification
Class II
Status
Terminated
Recall initiated
Oct 25, 2019
FDA report date
Nov 20, 2019
Quantity
6660 bottles
Recall type
Voluntary: Firm initiated
Recalling firm
Novitium Pharma LLC

Original FDA data

Every field from FDA enforcement report D-0313-2020, exactly as published.

Show all FDA fields
City
East Windsor
State
NJ
Status
Terminated
Country
United States
Event ID
84147
Address
70 Lake Dr
Code information
all lots within expiry.
Postal code
08520-5321
Report date
Nov 20, 2019
Product type
Drugs
Recall number
D-0313-2020
Classification
Class II
Recalling firm
Novitium Pharma LLC
Product quantity
6660 bottles
Termination date
Mar 17, 2021
Reason for recall
CGMP Deviations: Presence of NDMA impurity detected in product.
Voluntary / mandated
Voluntary: Firm initiated
Product description
Novitium Pharma Ranitidine Capsules 300 mg 100 capsules Rx Only Manufactured by: Novitium Pharma LLC 70 Lake Drive, East Windsor, New Jersey 08520 NDC 70954-002-40
Distribution pattern
Nationwide
Recall initiation date
Oct 25, 2019
Initial firm notification
Letter
Center classification date
Nov 10, 2019

How we source this data

Source: U.S. Food and Drug Administration enforcement report D-0313-2020, published Nov 20, 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.

How we source and update recall data · Report incorrect information

Other recent drug recalls