D-1630-2019 Class II Terminated
FDA drug recall D-1630-2019 was initiated by LNK International, Inc. on Jul 10, 2019 and is designated Class II. Reason for recall: Microbial contamination of non-sterile product The recall status is terminated (terminated Jun 9, 2023). Affected quantity: P300456, P300475 and P300489 (Total - 13,500 liters) and P300482 - 3,600 liter.
Recall Details
- Product Type
- Drugs
- Report Date
- Aug 7, 2019
- Initiation Date
- Jul 10, 2019
- Termination Date
- Jun 9, 2023
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- P300456, P300475 and P300489 (Total - 13,500 liters) and P300482 - 3,600 liter
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
Reason for Recall
Microbial contamination of non-sterile product
Distribution Pattern
USA Nationwide
Code Information
Lot #: P300456, P300475,P300482, P300489, Exp 09/30/2020
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-1630-2019
- openFDA file date
- Nov 3, 2026
- Loaded by RegDataLab
- Nov 4, 2026