January 2020 FDA Recall Drug by Spectrum Laboratory Products
D-0825-2020 - CGMP Deviations

This Class II drug recall was voluntarily initiated by Spectrum Laboratory Products on January 14, 2020 for the product Drug. The FDA reported the reason for recall as cgmp deviations. The product was distributed in The recalled API was distributed to pharmacies in the following states: AZ, CA, FL, GA, NJ, PA, RI, SC, TX, UT, WY. The API was also distributed internationally to Canada and UAE. and the recall is currently terminated.

Recall Number: D-0825-2020

Reason for Recall
CGMP Deviations: Presence of NDMA impurity detected in product.
Initiated
01-14-2020
Reported
02-12-2020
Quantity
N/A

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
84799
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.
Spectrum Laboratory Products
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.
The recalled API was distributed to pharmacies in the following states: AZ, CA, FL, GA, NJ, PA, RI, SC, TX, UT, WY. The API was also distributed internationally to Canada and UAE.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
12-05-2023
Product Description About Product Description
Full technical description of the product.
Ranitidine Hydrochloride (powder), USP, Rx only, Spectrum Chemical Mfg Corp., a) 1 gram, b) 5 grams, c) 25 grams, d)100 grams, e) 500 grams, f) 1 Kilogram

Batch or Lot Expiration Information

Lot# :11E0585, Exp. October 2023