Desmopressin Acetate Tablets, 0.2 mg, 100-count bottles, Rx Only, Manufactured for: Northstar Rx LLC, Memphis, TN 38141,
Summary
The FDA issued a Class II for Desmopressin Acetate Tablets, 0.2 mg, 100-count bottles, Rx Only, Manufactured f by Glenmark Pharmaceuticals Inc., USA. Reason: CGMP Deviations.
Details
Source
Drug Recall
External ID
D-1171-2022
Action Date
2022-07-06
Status
Terminated
Category
drug
Product Description
Desmopressin Acetate Tablets, 0.2 mg, 100-count bottles, Rx Only, Manufactured for: Northstar Rx LLC, Memphis, TN 38141, Manufactured by: Glenmark Pharmaceuticals Ltd., Colvale-Bardez, Goa 403513, India, NDC 16714-884-01
Lot/Code Info: Lot #: 20020121, Exp 01/2024
Quantity Affected: 36 bottles
Reason for Recall
CGMP Deviations
Distribution
One sole distributor in TX
Type: Voluntary: Firm initiated
Recall Initiated: 2022-06-29
Company
Mahwah, NJ
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 29 drug recalls issued in the same week, part of 272 drug-related FDA actions this month.
Glenmark Pharmaceuticals Inc., USA has 123 FDA actions in our database, including 123 recalls.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Glenmark Pharmaceuticals Inc., USA) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Glenmark Pharmaceuticals Inc., USA have FDA actions?
Glenmark Pharmaceuticals Inc., USA has 123 FDA actions in our database, including 123 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "D-1171-2022" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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