November 2019 FDA Recall Drug by American Health Packaging
D-0631-2020 - CGMP Deviations

This Class II drug recall was voluntarily initiated by American Health Packaging on November 1, 2019 for the product Drug. The FDA reported the reason for recall as cgmp deviations. The product was distributed Nationwide and the recall is currently terminated.

Recall Number: D-0631-2020

Reason for Recall
CGMP Deviations: Presence of NDMA impurity detected in product.
Initiated
11-01-2019
Reported
01-08-2020
Quantity
1,692 cases of 40 and 50 cups

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
84208
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
American Health Packaging
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide USA
Termination Date About Termination Date
Date that FDA officially terminated the recall.
08-03-2022
Product Description About Product Description
Full technical description of the 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)

Batch or Lot Expiration Information

Lot# [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