MAJOR LubriFresh P.M. Nighttime Ointment, Lubricant Eye Ointment, Sterile, 0.125 OZ (3.5g), Distributed by: MAJOR PHARMA
Summary
The FDA issued a Class II for MAJOR LubriFresh P.M. Nighttime Ointment, Lubricant Eye Ointment, Sterile, 0.125 by AMMAN PHARMACEUTICAL INDUSTRIES. Reason: Lack of Assurance of Sterility.
Details
Source
Drug Recall
External ID
D-1160-2023
Action Date
2023-09-27
Status
Ongoing
Category
drug
Product Description
MAJOR LubriFresh P.M. Nighttime Ointment, Lubricant Eye Ointment, Sterile, 0.125 OZ (3.5g), Distributed by: MAJOR PHARMACEUTICALS, Indianapolis, IN 46268, Made in Jordan, NDC: 0904-6488-38.
Lot/Code Info: Lot: 184001 EXP: 11/24; 184002 EXP: 11/24; 184003 EXP: 11/24; Lot: 184004 EXP: 12/24; Lot: 184005 EXP: 12/24; Lot:184006 EXP:12/24;
Quantity Affected: 282,564 units
Reason for Recall
Lack of Assurance of Sterility
Distribution
Product was distributed to two (2) direct accounts in RI and CO.
Type: Voluntary: Firm initiated
Recall Initiated: 2023-09-01
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 47 drug recalls issued in the same week, part of 267 drug-related FDA actions this month.
AMMAN PHARMACEUTICAL INDUSTRIES has 17 FDA actions in our database, including 17 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 (AMMAN PHARMACEUTICAL INDUSTRIES) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does AMMAN PHARMACEUTICAL INDUSTRIES have FDA actions?
AMMAN PHARMACEUTICAL INDUSTRIES has 17 FDA actions in our database, including 17 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "D-1160-2023" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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