NAD+ Nicotinamide Adenine Dinucleotide, Lyophilized powder for reconstitution, Multi-Dose 500 mg per vial, Each ML conta
Summary
The FDA issued a Class II for NAD+ Nicotinamide Adenine Dinucleotide, Lyophilized powder for reconstitution, M by Olympia Compounding Pharmacy dba Olympia Pharmacy. Reason: Product found to be Sub Potent or Exceeded reconstitution time.
Details
Source
Drug Recall
External ID
D-0719-2022
Action Date
2022-03-30
Status
Terminated
Category
drug
Product Description
NAD+ Nicotinamide Adenine Dinucleotide, Lyophilized powder for reconstitution, Multi-Dose 500 mg per vial, Each ML contains: 0.288% Sodium Phosphate Monobasic USP, 0.42% Sodium Phosphate Dibasic USP, 5% Mannitol USP, Sterile Water for Injection USP, Rx Only, Olympia Pharmaceuticals 6700 Conroy Rd., Ste. 155, Orlando, FL 32835 NDC: 73198-0083-00
Lot/Code Info: Lot: D24005 Exp. 4/5/22; C41008 Exp. 3/8/22
Quantity Affected: 2634 vials
Reason for Recall
Product found to be Sub Potent or Exceeded reconstitution time
Distribution
Nationwide in the USA including Puerto Rico.
Type: Voluntary: Firm initiated
Recall Initiated: 2022-03-08
Company
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 78 drug recalls issued in the same week, part of 267 drug-related FDA actions this month.
Olympia Compounding Pharmacy dba Olympia Pharmacy has 94 FDA actions in our database, including 94 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 (Olympia Compounding Pharmacy dba Olympia Pharmacy) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Olympia Compounding Pharmacy dba Olympia Pharmacy have FDA actions?
Olympia Compounding Pharmacy dba Olympia Pharmacy has 94 FDA actions in our database, including 94 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "D-0719-2022" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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