Multi-event November 2016 FDA Recall Drug by Raritan Pharmaceuticals, Inc.

This Multi-event Class II drug recall was voluntarily initiated by Raritan Pharmaceuticals, Inc. on November 18, 2016 for the product Drug. The FDA reported the reason for recall as cgmp deviations. The product was distributed in NY and the recall is currently terminated.

Reported Recall Events

D-0233-2017 TERMINATED D-0232-2017 TERMINATED D-0234-2017 TERMINATED

Recall Number: D-0233-2017

Reason for Recall
CGMP Deviations
Initiated
11-18-2016
Reported
01-04-2017
Quantity
22,704 bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
75757
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.
Raritan 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.
NY
Termination Date About Termination Date
Date that FDA officially terminated the recall.
01-08-2020
Product Description About Product Description
Full technical description of the product.
Kids' Relief Ear Relief Oral Liquid 0.85 fl oz. (25 mL) 3025 de'l Assomption Blvd. Montreal, QC H1N 2H2 Canada NDC 60512-913-8 UPC 77815909639

Batch or Lot Expiration Information

Lot# 35254; Exp. 05/20

Recall Number: D-0232-2017

Reason for Recall
CGMP Deviations
Initiated
11-18-2016
Reported
01-04-2017
Quantity
45,648 bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
75757
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.
Raritan 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.
NY
Termination Date About Termination Date
Date that FDA officially terminated the recall.
01-08-2020
Product Description About Product Description
Full technical description of the product.
CVS Health Homeopathic Infants Teething Tablets 135 count bottle Distributed by: CVS Pharmacy, Inc. One CVS Drive, Woonsocket, RI 02895 NDC 59779-860-03 UPC 0504284162

Batch or Lot Expiration Information

Lot# : 41116, 43436; Exp. 03/20

Recall Number: D-0234-2017

Reason for Recall
CGMP Deviations
Initiated
11-18-2016
Reported
01-04-2017
Quantity
20,448 bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
75757
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.
Raritan 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.
NY
Termination Date About Termination Date
Date that FDA officially terminated the recall.
01-08-2020
Product Description About Product Description
Full technical description of the product.
CVS pharmacy Kids' Ear Relief Oral Liquid 0.85 oz (25 mL) Distributed by: CVS Pharmacy, Inc. One CVS Drive Woonsocket RI 02895 NDC 59779-687-02 UPC 77815909639

Batch or Lot Expiration Information

Lot# 33149; Exp. 01/20