Why it was recalled
CGMP Deviations: Presence of NDMA impurity detected in product.
Product description
Ranitidine Tablets, USP 75 mg, a.) 30- count bottles (NDC 0363-0131-30), b.) 80-count bottles (NDC 0363-0131-80) (Walgreens) OTC
Lot numbers, UPCs & expiration codes
Batch Numbers: All lots within expiry.
Where it was sold
Product was distributed to major distributors throughout the United States who may have further distributed the product.
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-0183-2020
- Classification
- Class II
- Status
- Completed
- Recall initiated
- Oct 1, 2019
- FDA report date
- Nov 13, 2019
- Quantity
- N/A
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Dr. Reddy's Laboratories, Inc.
Original FDA data
Every field from FDA enforcement report D-0183-2020, exactly as published.
Show all FDA fields
- City
- Princeton
- State
- NJ
- Status
- Completed
- Country
- United States
- Event ID
- 83908
- Address
- 107 College Rd E
- Code information
- Batch Numbers: All lots within expiry.
- Postal code
- 08540-6623
- Report date
- Nov 13, 2019
- Product type
- Drugs
- Recall number
- D-0183-2020
- Classification
- Class II
- Recalling firm
- Dr. Reddy's Laboratories, Inc.
- Reason for recall
- CGMP Deviations: Presence of NDMA impurity detected in product.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Ranitidine Tablets, USP 75 mg, a.) 30- count bottles (NDC 0363-0131-30), b.) 80-count bottles (NDC 0363-0131-80) (Walgreens) OTC
- Distribution pattern
- Product was distributed to major distributors throughout the United States who may have further distributed the product.
- Recall initiation date
- Oct 1, 2019
- Initial firm notification
- Letter
- Center classification date
- Nov 5, 2019