Nighttime Sleep Aid Solution
FDA Recall NDC 49035-330
FDA Enforcement Report: View Recall Date, Reasons, and Safety Status
Active & Historical Enforcement Reports
The FDA has identified 1 recorded enforcement report(s) associated with Nighttime Sleep Aid (NDC 49035-330). A significant event, classified as Class II, was initiated on Jul 10, 2019 by Wal-mart Stores Inc. The reported reason for this action was: "Microbial contamination of non-sterile product"
This specific recall has a current status of TERMINATED, indicating that the FDA considers the recall process finished or the product successfully recovered.
This specific recall has a current status of TERMINATED, indicating that the FDA considers the recall process finished or the product successfully recovered.
Reported Recall Events
Class II Terminated
Microbial contamination of non-sterile product
Jul 10, 2019
Aug 07, 2019
P300456, P300475 and P300489 (Total - 13,500 liters) and P300482 - 3,600 liter
Recall Profile & Regulatory Data
Event ID
83315
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
LNK International, Inc.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
USA Nationwide
Termination Date
Jun 09, 2023
Product Description
Equate Night-time Sleep Aide (Diphenhydramine HCl), 50 mg, Alcohol Free, Berry Flavor, 12 Fl. Oz. (354 mL), OTC, Distributed by: Walmart Stores, Inc., Bentonville, AR 72716, NDC 49035-330-02, UPC 6 8113117595 1
Batch or Lot Expiration Information
Lot# : P300456, P300475,P300482, P300489, Exp 09/30/2020
Affected Packages Involved in this Recall
49035-330-45Product
49035-330-02Product
49035-330-96Product
8113117595Product
About FDA Recall Enforcement Reports
FDA recall data documents classified recall actions associated with a product. Most recalls are limited to specific lots, batches, or package configurations rather than every unit of a drug.
If a recall is listed for an NDC, review the affected lot information and package details carefully. Patients and healthcare professionals should confirm whether a specific product in hand matches the lot or package information before assuming it is affected.
