Recalls / Class II
Class IID-1630-2019
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
- Brand name
- Nighttime Sleep Aid
- Generic name
- Diphenhydramine Hcl
- Active ingredient
- Diphenhydramine Hydrochloride
- Route
- Oral
- NDC
- 49035-330
- FDA application
- M010
- Affected lot / code info
- Lot #: P300456, P300475,P300482, P300489, Exp 09/30/2020
Why it was recalled
Microbial contamination of non-sterile product
Recalling firm
- Firm
- LNK International, Inc.
- Manufacturer
- Wal-Mart Stores Inc
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 55 Arkay Dr, N/A, Hauppauge, New York 11788-3707
Distribution
- Quantity
- P300456, P300475 and P300489 (Total - 13,500 liters) and P300482 - 3,600 liter
- Distribution pattern
- USA Nationwide
Timeline
- Recall initiated
- 2019-07-10
- FDA classified
- 2019-08-06
- Posted by FDA
- 2019-08-07
- Terminated
- 2023-06-09
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-1630-2019. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.