November 2020 FDA Recall Drug by Us Pharmaceuticals Inc.
D-0113-2021 - Lack Of CGMP

This Class II drug recall was voluntarily initiated by Us Pharmaceuticals Inc. on November 19, 2020 for the product Drug. The FDA reported the reason for recall as lack of cgmp. The product was distributed in Distributed in RI and the recall is currently terminated.

Recall Number: D-0113-2021

Reason for Recall
Lack Of CGMP:s Low weight fill tubes were identified in one lot of CVS Healing Ointment.
Initiated
11-19-2020
Reported
12-09-2020
Quantity
3312 units

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
86868
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.
US Pharmaceuticals Inc.
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.
Distributed in RI
Termination Date About Termination Date
Date that FDA officially terminated the recall.
02-01-2022
Product Description About Product Description
Full technical description of the product.
CVS Health Hydrating Healing Ointment (Petrolatum 41%), Net Wt 3 OZ (85g), Distributed by CVS Pharmacy, Inc. One CVS Drive, Woonsocket, RI 02895 UPC 0 50428 53642 1

Batch or Lot Expiration Information

Lot# 41C19 Exp 3/2021