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Class II: temporary or reversible health riskOngoing

Glenmark Ranitidine Tablets 300 mg Rx Only Recall

Glenmark Ranitidine Tablets USP 300 mg Rx Only 30 Tablets Manufactured by: Glenmark Pha…

Glenmark Pharmaceuticals Inc., USA · Mahwah, NJ

Risk level
Class II
Reported by FDA
Jan 15, 2020
Recall ID
D-0641-2020
Check your lot numberHow we source this data

Summary

Glenmark Pharmaceuticals recalled Glenmark Ranitidine Tablets 300 mg Rx Only starting Dec 17, 2019. The FDA classified it as Class II (temporary or reversible health risk) and published enforcement report D-0641-2020 on Jan 15, 2020. Reason: CGMP Deviations: Presence of NDMA impurity detected in product. Status: Ongoing.

Why it was recalled

CGMP Deviations: Presence of NDMA impurity detected in product.

Product description

Glenmark Ranitidine Tablets USP 300 mg Rx Only 30 Tablets Manufactured by: Glenmark Pharmaceuticals Ltd. Colvale-Bandez, Goa 403513, India Manufactured for: Glenmark Pharmaceuticals Inc., USA Mahwah, NJ NDC 68462-249-30

Lot numbers, UPCs & expiration codes

7701429A 7701522A 7702255A 7704745A 19190456 19190472 19190490

Where it was sold

Natiowide

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-0641-2020
Classification
Class II
Status
Ongoing
Recall initiated
Dec 17, 2019
FDA report date
Jan 15, 2020
Quantity
98,988 bottles
Recall type
Voluntary: Firm initiated
Recalling firm
Glenmark Pharmaceuticals Inc., USA

Original FDA data

Every field from FDA enforcement report D-0641-2020, exactly as published.

Show all FDA fields
City
Mahwah
State
NJ
Status
Ongoing
Country
United States
Event ID
84516
Address
750 Corporate Dr
Code information
7701429A 7701522A 7702255A 7704745A 19190456 19190472 19190490
Postal code
07430-2009
Report date
Jan 15, 2020
Product type
Drugs
Recall number
D-0641-2020
Classification
Class II
Recalling firm
Glenmark Pharmaceuticals Inc., USA
Product quantity
98,988 bottles
Reason for recall
CGMP Deviations: Presence of NDMA impurity detected in product.
Voluntary / mandated
Voluntary: Firm initiated
Product description
Glenmark Ranitidine Tablets USP 300 mg Rx Only 30 Tablets Manufactured by: Glenmark Pharmaceuticals Ltd. Colvale-Bandez, Goa 403513, India Manufactured for: Glenmark Pharmaceuticals Inc., USA Mahwah, NJ NDC 68462-249-30
Distribution pattern
Natiowide
Recall initiation date
Dec 17, 2019
Initial firm notification
Press Release
Center classification date
Jan 5, 2020

How we source this data

Source: U.S. Food and Drug Administration enforcement report D-0641-2020, published Jan 15, 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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