Why it was recalled
cGMP deviations
Product description
Legatrin PM Pain Reliever/Sleep Aid (acetaminophen 500 mg, diphenhydramine HCl 50mg caplets) 50-count bottles, Manufactured for: Church & Dwight Co., Inc. Ewing, NJ 08628 NDC 10237-907-50
Lot numbers, UPCs & expiration codes
Lot #: HY9042, Exp. Date 02/2022; HY9094, HY9112, Exp. Date 04/2022; HY9134, Exp. Date 05/2022; HY9267, Exp. Date 09/2022
Where it was sold
Nationwide within the United States
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-0470-2022
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Jan 24, 2022
- FDA report date
- Feb 9, 2022
- Quantity
- 174,852 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Ultra Seal Corporation
Original FDA data
Every field from FDA enforcement report D-0470-2022, exactly as published.
Show all FDA fields
- City
- New Paltz
- State
- NY
- Status
- Terminated
- Country
- United States
- Event ID
- 89464
- Address
- 521 Main St
- Code information
- Lot #: HY9042, Exp. Date 02/2022; HY9094, HY9112, Exp. Date 04/2022; HY9134, Exp. Date 05/2022; HY9267, Exp. Date 09/2022
- Postal code
- 12561-1609
- Report date
- Feb 9, 2022
- Product type
- Drugs
- Recall number
- D-0470-2022
- Classification
- Class II
- Recalling firm
- Ultra Seal Corporation
- Product quantity
- 174,852 bottles
- Termination date
- Oct 16, 2023
- Reason for recall
- cGMP deviations
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Legatrin PM Pain Reliever/Sleep Aid (acetaminophen 500 mg, diphenhydramine HCl 50mg caplets) 50-count bottles, Manufactured for: Church & Dwight Co., Inc. Ewing, NJ 08628 NDC 10237-907-50
- Distribution pattern
- Nationwide within the United States
- Recall initiation date
- Jan 24, 2022
- Initial firm notification
- Letter
- Center classification date
- Jan 31, 2022