Why it was recalled
CGMP Deviations: N-nitrosodimethylamine (NDMA) has been detected in Ranitidine tablets, capsules and syrups.
Product description
DG Health Acid Reducer Ranitidine Tablets 150 mg, 8-count carton, Distributed by: Dolgencorp LLC 100 Mission Ridge Goodletville TN 37072 NDC 55910-092-79
Lot numbers, UPCs & expiration codes
Lot # NBSB19001DA3; Exp FEB 2021
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-0526-2020
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- Nov 6, 2019
- FDA report date
- Dec 4, 2019
- Quantity
- 69,696 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- AuroMedics Pharma LLC
Original FDA data
Every field from FDA enforcement report D-0526-2020, exactly as published.
Show all FDA fields
- City
- East Windsor
- State
- NJ
- Status
- Ongoing
- Country
- United States
- Event ID
- 84218
- Address
- 279 Princeton Hightstown Rd
- Code information
- Lot # NBSB19001DA3; Exp FEB 2021
- Postal code
- 08520-1401
- Report date
- Dec 4, 2019
- Product type
- Drugs
- Recall number
- D-0526-2020
- Classification
- Class II
- Recalling firm
- AuroMedics Pharma LLC
- Product quantity
- 69,696 bottles
- Reason for recall
- CGMP Deviations: N-nitrosodimethylamine (NDMA) has been detected in Ranitidine tablets, capsules and syrups.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- DG Health Acid Reducer Ranitidine Tablets 150 mg, 8-count carton, Distributed by: Dolgencorp LLC 100 Mission Ridge Goodletville TN 37072 NDC 55910-092-79
- Distribution pattern
- nationwide
- Recall initiation date
- Nov 6, 2019
- Initial firm notification
- Press Release
- Center classification date
- Nov 26, 2019