Drug product
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
D-0080-2024
Product summary
- Event
- Event 93236
- Status
- Terminated
- Classification
- Class III
- Quantity
- 4548 bottles
- Official record key
drug-enforcement:D-0080-2024
Official wording
Reason: Subpotent Drug
Code information: Lot#: 23ZCP1, Exp. Date 02/22/2026;Lot #:23ZDR1, Exp. Date 03/09/2026
Distribution pattern: Nationwide within the United States
Derived failure modes
-
Potency or specification failure
Subpotent