Why it was recalled
CGMP Deviations: use of non-food grade lubricant in mixing vessel.
Product description
Safe Tussin PM Night Time Cough Relief (Cough Suppressant/Antihistamine), packaged in 4.0 FL OZ(118mL) bottles, Kramer Laboratories, Inc. Bridgewater, NJ 08807
Lot numbers, UPCs & expiration codes
Lot #: 8639, Exp. Date 8/2023
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-0943-2023
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Jun 23, 2023
- FDA report date
- Aug 2, 2023
- Quantity
- N/A
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Kramer Laboratories, Inc.
Original FDA data
Every field from FDA enforcement report D-0943-2023, exactly as published.
Show all FDA fields
- City
- Bridgewater
- State
- NJ
- Status
- Terminated
- Country
- United States
- Event ID
- 92407
- Address
- 440 Us Highway 22 Ste 210
- Code information
- Lot #: 8639, Exp. Date 8/2023
- Postal code
- 08807-2477
- Report date
- Aug 2, 2023
- Product type
- Drugs
- Recall number
- D-0943-2023
- Classification
- Class II
- Recalling firm
- Kramer Laboratories, Inc.
- Termination date
- Mar 12, 2024
- Reason for recall
- CGMP Deviations: use of non-food grade lubricant in mixing vessel.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Safe Tussin PM Night Time Cough Relief (Cough Suppressant/Antihistamine), packaged in 4.0 FL OZ(118mL) bottles, Kramer Laboratories, Inc. Bridgewater, NJ 08807
- Distribution pattern
- nationwide within the United States
- Recall initiation date
- Jun 23, 2023
- Initial firm notification
- Letter
- Center classification date
- Jul 24, 2023