Amneal Pharmaceuticals Ranitidine Tablets Recall

CGMP Deviations: Impurity N-nitrosodimethylamine (NDMA) found in API

Ranitidine Tablets, USP 150 mg a).60-count bottles (NDC 65162-253-06) , b).100-count bottles (NDC 65162-253-10), c).180-count bottles (NDC 65162-253-18), d).500-count bottles (NDC 65162-253-50) and e)1000-count bottles (NDC 65162-253-11).

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Product was distributed throughout the United States.

• 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 number

D-0612-2020

Classification

Class II

Status

Ongoing

Recall initiated

Nov 22, 2019

FDA report date

Dec 18, 2019

Quantity

N/A

Recall type

Voluntary: Firm initiated

Recalling firm

Amneal Pharmaceuticals, Inc.