Why it was recalled
CGMP DEVIATIONS: One lot of Ranitidine Tablets USP, 150 mg is being recalled because some bottles were empty.
Product description
Ranitidine Tablets USP,150 mg, 8-count bottles, Distributed by: Dolgencorp, LLC, 100 Mission Ridge, Goodlettsville, TN 37073 Made in India NDC 55910-092-79
Lot numbers, UPCs & expiration codes
Lot #: NBSB19001DA3, Exp. date 02/2021
Where it was sold
Nationwide within the United States
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-0166-2020
- Classification
- Class III
- Status
- Ongoing
- Recall initiated
- Sep 23, 2019
- FDA report date
- Nov 6, 2019
- Quantity
- 69696 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- AuroMedics Pharma LLC
Original FDA data
Every field from FDA enforcement report D-0166-2020, exactly as published.
Show all FDA fields
- City
- East Windsor
- State
- NJ
- Status
- Ongoing
- Country
- United States
- Event ID
- 83868
- Address
- 279 Princeton Hightstown Rd
- Code information
- Lot #: NBSB19001DA3, Exp. date 02/2021
- Postal code
- 08520-1401
- Report date
- Nov 6, 2019
- Product type
- Drugs
- Recall number
- D-0166-2020
- Classification
- Class III
- Recalling firm
- AuroMedics Pharma LLC
- Product quantity
- 69696 bottles
- Reason for recall
- CGMP DEVIATIONS: One lot of Ranitidine Tablets USP, 150 mg is being recalled because some bottles were empty.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Ranitidine Tablets USP,150 mg, 8-count bottles, Distributed by: Dolgencorp, LLC, 100 Mission Ridge, Goodlettsville, TN 37073 Made in India NDC 55910-092-79
- Distribution pattern
- Nationwide within the United States
- Recall initiation date
- Sep 23, 2019
- Initial firm notification
- Letter
- Center classification date
- Oct 29, 2019