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
2Lot 187652, exp 05/31/2021
3[Case of 50] Lot 177874, exp 01/31/ 2020
4Lot 178413, exp 02/29/ 2020
5Lot 183449, exp 10/31/2020
6Lot 184445, exp 12/31/ 2020
7Lot 186563, exp 03/31/ 2021
8Lot 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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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA drug enforcement) notice

Notice updated Aug 3, 2022 · Data as of Sep 19, 6:34 PM UTC

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