Why it was recalled
CGMP Deviations: Presence of NDMA impurity detected in product.
Product description
Ranitidine Syrup (Ranitidine Oral Solution USP), 15 mg/mL, 150 mg/10 mL per cup, Rx Only, Distributed by: American Health Packaging, Columbus, Ohio. (a) Case of 50 cups (NDC 60687-260-69) (b) Case of 40 cups (NDC 60687-260-23 (c) Unit Dose Cup (NDC 60687-260-69)
Lot numbers, UPCs & expiration codes
[Case of 40] Lots 183723, 184278, exp 10/31/2020; Lot 187652, exp 05/31/2021; [Case of 50] Lot 177874, exp 01/31/ 2020; Lot 178413, exp 02/29/ 2020; Lot 183449, exp 10/31/2020; Lot 184445, exp 12/31/ 2020; Lot 186563, exp 03/31/ 2021; Lot 187691, exp 05/31/2021
Where it was sold
Nationwide USA
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-0631-2020
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Nov 1, 2019
- FDA report date
- Jan 8, 2020
- Quantity
- 1,692 cases of 40 and 50 cups
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- American Health Packaging
Original FDA data
Every field from FDA enforcement report D-0631-2020, exactly as published.
Show all FDA fields
- City
- Columbus
- State
- OH
- Status
- Terminated
- Country
- United States
- Event ID
- 84208
- Address
- 2550 John Glenn Ave Ste A
- Code information
- [Case of 40] Lots 183723, 184278, exp 10/31/2020; Lot 187652, exp 05/31/2021; [Case of 50] Lot 177874, exp 01/31/ 2020; Lot 178413, exp 02/29/ 2020; Lot 183449, exp 10/31/2020; Lot 184445, exp 12/31/ 2020; Lot 186563, exp 03/31/ 2021; Lot 187691, exp 05/31/2021
- Postal code
- 43217-1188
- Report date
- Jan 8, 2020
- Product type
- Drugs
- Recall number
- D-0631-2020
- Classification
- Class II
- Recalling firm
- American Health Packaging
- Product quantity
- 1,692 cases of 40 and 50 cups
- Termination date
- Aug 3, 2022
- Reason for recall
- CGMP Deviations: Presence of NDMA impurity detected in product.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Ranitidine Syrup (Ranitidine Oral Solution USP), 15 mg/mL, 150 mg/10 mL per cup, Rx Only, Distributed by: American Health Packaging, Columbus, Ohio. (a) Case of 50 cups (NDC 60687-260-69) (b) Case of 40 cups (NDC 60687-260-23 (c) Unit Dose Cup (NDC 60687-260-69)
- Distribution pattern
- Nationwide USA
- Recall initiation date
- Nov 1, 2019
- Initial firm notification
- Letter
- Center classification date
- Dec 29, 2019