Why it was recalled
CGMP Deviations: Presence of NDMA impurity detected in product.
Product description
Preferred Pharmaceuticals, Inc, Ranitidine Tablets, 150 mg, a) 30 count bottles (NDC: 68788-7388-3), b) 60 count bottles (NDC: 68788-7388-6), c) 90 count bottles (NDC: 68788-7388-9), d) 100 count bottles (NDC: 68788-7388-1)
Lot numbers, UPCs & expiration codes
Lot #: All lots within expiry
Where it was sold
Distribution to physicians in the following states: AL, AZ, CA, FL, GA, IN, and SC
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-0796-2020
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Jan 7, 2020
- FDA report date
- Jan 29, 2020
- Quantity
- 221,710 tablets
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Preferred Pharmaceuticals, Inc
Original FDA data
Every field from FDA enforcement report D-0796-2020, exactly as published.
Show all FDA fields
- City
- Anaheim
- State
- CA
- Status
- Terminated
- Country
- United States
- Event ID
- 84671
- Address
- 1250 N Lakeview Ave Ste O
- Code information
- Lot #: All lots within expiry
- Postal code
- 92807-1801
- Report date
- Jan 29, 2020
- Product type
- Drugs
- Recall number
- D-0796-2020
- Classification
- Class II
- Recalling firm
- Preferred Pharmaceuticals, Inc
- Product quantity
- 221,710 tablets
- Termination date
- Dec 14, 2023
- Reason for recall
- CGMP Deviations: Presence of NDMA impurity detected in product.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Preferred Pharmaceuticals, Inc, Ranitidine Tablets, 150 mg, a) 30 count bottles (NDC: 68788-7388-3), b) 60 count bottles (NDC: 68788-7388-6), c) 90 count bottles (NDC: 68788-7388-9), d) 100 count bottles (NDC: 68788-7388-1)
- Distribution pattern
- Distribution to physicians in the following states: AL, AZ, CA, FL, GA, IN, and SC
- Recall initiation date
- Jan 7, 2020
- Initial firm notification
- Telephone
- Center classification date
- Jan 20, 2020