Why it was recalled
CGMP Deviations: Presence of NDMA impurity detected in product.
Product description
Ranitidine 150 mg, a) 60 Tabs (NDC 61919-339-60); and b) 90 Tabs (NDC 61919-339-90) bottles, Rx only, Packaged and Distributed By: Direct Rx Dawsonville, GA 30534
Lot numbers, UPCs & expiration codes
Lots: a) 09AU1911 Exp. 02/28/2022; b) 09SE1904 Exp. 03/31/2022
Where it was sold
FL, GA
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-0016-2021
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Jan 15, 2020
- FDA report date
- Oct 14, 2020
- Quantity
- a) 54 bottles; b) 26 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Direct Rx
Original FDA data
Every field from FDA enforcement report D-0016-2021, exactly as published.
Show all FDA fields
- City
- Dawsonville
- State
- GA
- Status
- Terminated
- Country
- United States
- Event ID
- 86498
- Address
- 94 Worldwide Dr
- Code information
- Lots: a) 09AU1911 Exp. 02/28/2022; b) 09SE1904 Exp. 03/31/2022
- Postal code
- 30534-6828
- Report date
- Oct 14, 2020
- Product type
- Drugs
- Recall number
- D-0016-2021
- Classification
- Class II
- Recalling firm
- Direct Rx
- Product quantity
- a) 54 bottles; b) 26 bottles
- Termination date
- Dec 7, 2020
- Reason for recall
- CGMP Deviations: Presence of NDMA impurity detected in product.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Ranitidine 150 mg, a) 60 Tabs (NDC 61919-339-60); and b) 90 Tabs (NDC 61919-339-90) bottles, Rx only, Packaged and Distributed By: Direct Rx Dawsonville, GA 30534
- Distribution pattern
- FL, GA
- Recall initiation date
- Jan 15, 2020
- Initial firm notification
- Letter
- Center classification date
- Oct 5, 2020