September 2019 FDA Recall Drug by Spectrum Laboratory Products
D-0141-2020 - CGMP Deviations
This Class II drug recall was voluntarily initiated by Spectrum Laboratory Products on September 12, 2019 for the product Drug. The FDA reported the reason for recall as cgmp deviations. The product was distributed in Product was distributed to compounding pharmacies and labs in CA, CO, MD, SC. and the recall is currently terminated.
Recall Number: D-0141-2020
CGMP Deviations: Received notice from supplier that there is potential glass contamination.
09-12-2019
10-23-2019
29.1 grams
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.
Spectrum Laboratory Products
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.
Product was distributed to compounding pharmacies and labs in CA, CO, MD, SC.
11-10-2020
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
Fentanyl Citrate USP, Active Pharmaceutical Ingredient, Spectrum Chemical MFG. CORP., Gardena, CA 90248 NDC 49452-0032-06
Batch or Lot Expiration Information
Lot# 1HE0899, 1IB0005, Exp 02/28/2023
