July 2019 FDA Recall Nighttime Sleep Aid by Lnk International, Inc.
D-1630-2019 - Microbial contamination of non-sterile product
This Class II drug recall was voluntarily initiated by Lnk International, Inc. on July 10, 2019 for the product Nighttime Sleep Aid. The FDA reported the reason for recall as microbial contamination of non-sterile product. The product was distributed Nationwide and the recall is currently terminated.
Recall Number: D-1630-2019
Microbial contamination of non-sterile product
07-10-2019
08-07-2019
P300456, P300475 and P300489 (Total - 13,500 liters) and P300482 - 3,600 liter
Recall Profile & Regulatory Data
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
LNK International, Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
USA Nationwide
06-09-2023
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
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
