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Recall Observatory FDA recall evidence

Drug product

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)

D-0631-2020

November 01, 2019

Class II

Product summary

Firm
American Health Packaging
Event
Event 84208
Status
Terminated
Classification
Class II
Quantity
1,692 cases of 40 and 50 cups
Official record key
drug-enforcement:D-0631-2020

Official wording

Reason: CGMP Deviations: Presence of NDMA impurity detected in product.

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

Distribution pattern: Nationwide USA

Derived failure modes

  • Foreign material or chemical contamination

    reason.foreign_material_chemical_contamination · v1.0.0

    NDMA impurity
  • Manufacturing or process control

    reason.manufacturing_process_control · v1.0.0

    CGMP Deviations