November 2019 FDA Recall Drug by Precision Dose Inc.
D-1004-2020 - CGMP Deviations

This Class II drug recall was voluntarily initiated by Precision Dose Inc. on November 13, 2019 for the product Drug. The FDA reported the reason for recall as cgmp deviations. The product was distributed Nationwide and the recall is currently terminated.

Recall Number: D-1004-2020

Reason for Recall
CGMP Deviations: Impurity N-nitrosodimethylamine (NDMA) found in API.
Initiated
11-13-2019
Reported
03-18-2020
Quantity
224,940 unit dose cups

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
85039
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.
Precision Dose 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.
Nationwide USA
Termination Date About Termination Date
Date that FDA officially terminated the recall.
09-17-2022
Product Description About Product Description
Full technical description of the product.
Ranitidine Oral Solution, USP, 150 mg/10 mL, [10 mL x 30 Unit Dose Cups per case, NDC: 68094-204-62; 10 mL x 100 Unit Dose Cups per case, NDC: 68094-204-61; Unit Dose Cup NDC: 68094-204-59], Rx only, Precision Dose, Inc., South Beloit, IL 61080

Batch or Lot Expiration Information

Lot# Lot number: 501290, Expiry: 11/30/19, NDC: 68094-204-61; Lot number: 501326, Expiry: 11/30/19, NDC: 68094-204-62; Lot number: 501501, Expiry: 11/30/19, NDC: 68094-204-62; Lot number: 1592, Expiry: 4/30/20, NDC: 68094-204-62; Lot number: 501679, Expiry: 4/30/20, NDC: 68094-204-61, 68094-204-62