Why it was recalled
Subpotent Drug
Product description
Opium Tincture, USP (Deodorized), 10 mg/mL of anhydrous morphine, packaged in 118 mL (4 Fl oz) bottles, Rx only, Manufactured for: Edenbridge Pharmaceuticals, LLC Parsippany, NJ 07054, NDC 42799-217-01
Lot numbers, UPCs & expiration codes
Lot#: 23ZCP1, Exp. Date 02/22/2026;Lot #:23ZDR1, Exp. Date 03/09/2026
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-0080-2024
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- Oct 20, 2023
- FDA report date
- Nov 8, 2023
- Quantity
- 4548 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Edenbridge Pharmaceuticals, LLC
Original FDA data
Every field from FDA enforcement report D-0080-2024, exactly as published.
Show all FDA fields
- City
- Parsippany
- State
- NJ
- Status
- Terminated
- Country
- United States
- Event ID
- 93236
- Address
- 1 Upper Pond Rd
- Address (line 2)
- Ste 250
- Code information
- Lot#: 23ZCP1, Exp. Date 02/22/2026;Lot #:23ZDR1, Exp. Date 03/09/2026
- Postal code
- 07054-1050
- Report date
- Nov 8, 2023
- Product type
- Drugs
- Recall number
- D-0080-2024
- Classification
- Class III
- Recalling firm
- Edenbridge Pharmaceuticals, LLC
- Product quantity
- 4548 bottles
- Termination date
- Aug 16, 2024
- Reason for recall
- Subpotent Drug
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Opium Tincture, USP (Deodorized), 10 mg/mL of anhydrous morphine, packaged in 118 mL (4 Fl oz) bottles, Rx only, Manufactured for: Edenbridge Pharmaceuticals, LLC Parsippany, NJ 07054, NDC 42799-217-01
- Distribution pattern
- Nationwide within the United States
- Recall initiation date
- Oct 20, 2023
- Initial firm notification
- Letter
- Center classification date
- Oct 30, 2023