Why it was recalled
Microbial contamination of non-sterile product
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
Lot numbers, UPCs & expiration codes
Lot #: P300456, P300475,P300482, P300489, Exp 09/30/2020
Where it was sold
USA Nationwide
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-1630-2019
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Jul 10, 2019
- FDA report date
- Aug 7, 2019
- Quantity
- P300456, P300475 and P300489 (Total - 13,500 liters) and P300482 - 3,600 liter
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- LNK International, Inc.
Original FDA data
Every field from FDA enforcement report D-1630-2019, exactly as published.
Show all FDA fields
- City
- Hauppauge
- State
- NY
- Status
- Terminated
- Country
- United States
- Event ID
- 83315
- Address
- 55 Arkay Dr
- Code information
- Lot #: P300456, P300475,P300482, P300489, Exp 09/30/2020
- Postal code
- 11788-3707
- Report date
- Aug 7, 2019
- Product type
- Drugs
- Recall number
- D-1630-2019
- Classification
- Class II
- Recalling firm
- LNK International, Inc.
- Product quantity
- P300456, P300475 and P300489 (Total - 13,500 liters) and P300482 - 3,600 liter
- Termination date
- Jun 9, 2023
- Reason for recall
- Microbial contamination of non-sterile product
- Voluntary / mandated
- Voluntary: Firm initiated
- 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
- Distribution pattern
- USA Nationwide
- Recall initiation date
- Jul 10, 2019
- Initial firm notification
- Letter
- Center classification date
- Aug 6, 2019