ProtectoRx (ethyl alcohol 70%), packaged in a) 2 FL OZ (59 mL), NDC 75408-002-01 and b) 16 FL OZ (473.2 mL), NDC 75408-0
Summary
The FDA issued a Class II for ProtectoRx (ethyl alcohol 70%), packaged in a) 2 FL OZ (59 mL), NDC 75408-002-01 by DIBAR NUTRICIONAL S DE RL DE CV. Reason: CGMP Deviations: Other lots and products of hand sanitizer recalled because they were manufactured under the same conditions as the product lots found.
Details
Source
Drug Recall
External ID
D-0646-2021
Action Date
2021-07-07
Status
Terminated
Category
drug
Product Description
ProtectoRx (ethyl alcohol 70%), packaged in a) 2 FL OZ (59 mL), NDC 75408-002-01 and b) 16 FL OZ (473.2 mL), NDC 75408-002-02 bottles, Imported by: Dibar Labs, LLC., Sugar Land, TX 77479; Distributed by: PR Trading LLC, PO Box 19647, San Juan, PR 00910, Made in Mexico.
Lot/Code Info: All lots.
Quantity Affected: Unknown quantity
Reason for Recall
CGMP Deviations: Other lots and products of hand sanitizer recalled because they were manufactured under the same conditions as the product lots found to contain methanol.
Distribution
Distributed Nationwide in the USA
Type: Voluntary: Firm initiated
Recall Initiated: 2021-05-11
Company
Morelia, N/A
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 19 drug recalls issued in the same week, part of 267 drug-related FDA actions this month.
DIBAR NUTRICIONAL S DE RL DE CV has 4 FDA actions in our database, including 4 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 (DIBAR NUTRICIONAL S DE RL DE CV) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does DIBAR NUTRICIONAL S DE RL DE CV have FDA actions?
DIBAR NUTRICIONAL S DE RL DE CV has 4 FDA actions in our database, including 4 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "D-0646-2021" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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