Reported Jan 8, 2020 · Terminated
Ranitidine Syrup (Ranitidine Oral Solution USP), 15 mg/mL, 150 mg/10 mL per cup, Rx Only, Distributed by: American…
American Health Packaging
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: American Health Packaging · 2550 John Glenn Ave Ste A · Columbus, OH · 43217-1188
Is this the product you have?
- Ranitidine Syrup (Ranitidine Oral Solution USP), 15 mg/mL, 150 mg/10 mL per cup, Rx Only
- Distributed byAmerican 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 codes and dates
8 of 8 products
Products covered by this recall # Product as published 1 [Case of 40] Lots 183723, 184278, exp 10/31/2020 2 Lot 187652, exp 05/31/2021 3 [Case of 50] Lot 177874, exp 01/31/ 2020 4 Lot 178413, exp 02/29/ 2020 5 Lot 183449, exp 10/31/2020 6 Lot 184445, exp 12/31/ 2020 7 Lot 186563, exp 03/31/ 2021 8 Lot 187691, exp 05/31/2021 - Amount recalled
- 1,692 cases of 40 and 50 cups
Where it was sold
- Nationwide
Why it was recalled
CGMP Deviations: Presence of NDMA impurity detected in product.
This product could cause temporary or reversible health problems — stop using it.
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