February 2018 FDA Recall Drug by Mckesson Packaging Services
D-0914-2018 - Failed Stability Specifications
This Class II drug recall was voluntarily initiated by Mckesson Packaging Services on February 26, 2018 for the product Drug. The FDA reported the reason for recall as failed stability specifications. The product was distributed Nationwide and the recall is currently terminated.
Recall Number: D-0914-2018
Failed Stability Specifications
02-26-2018
03-14-2018
17,192 cartons (1,719,200 tablets)
Recall Profile & Regulatory Data
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.
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
Mckesson Packaging Services
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Nationwide
09-15-2020
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
RANITIDINE Tablets, USP 150 mg UD 100 tablets (10x10), RX Only, Manufactured by: Amneal Pharmaceuticals, Hauppauge, NY 11788, NDC 63739-489-10
Batch or Lot Expiration Information
Lot# Lots: 0113064 Exp. 03/2018, 0114628 Exp. 08/2018, 0115189 Exp. 08/2018, 0115462 Exp. 09/2018
