Drug 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
D-1630-2019
Product summary
- Event
- Event 83315
- Status
- Terminated
- Classification
- Class II
- Quantity
- P300456, P300475 and P300489 (Total - 13,500 liters) and P300482 - 3,600 liter
- Official record key
drug-enforcement:D-1630-2019
Official wording
Reason: Microbial contamination of non-sterile product
Code information: Lot #: P300456, P300475,P300482, P300489, Exp 09/30/2020
Distribution pattern: USA Nationwide
Derived failure modes
-
Microbial contamination
Microbial contamination