Recalls / Class III
Class IIID-0080-2024
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
- Brand name
- Opium Tincture Deodorized
- Generic name
- Morphine
- Active ingredient
- Morphine
- Route
- Oral
- NDC
- 42799-217
- Affected lot / code info
- Lot#: 23ZCP1, Exp. Date 02/22/2026;Lot #:23ZDR1, Exp. Date 03/09/2026
Why it was recalled
Subpotent Drug
Recalling firm
- Firm
- Edenbridge Pharmaceuticals, LLC
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 1 Upper Pond Rd, Ste 250, Parsippany, New Jersey 07054-1050
Distribution
- Quantity
- 4548 bottles
- Distribution pattern
- Nationwide within the United States
Timeline
- Recall initiated
- 2023-10-20
- FDA classified
- 2023-10-30
- Posted by FDA
- 2023-11-08
- Terminated
- 2024-08-16
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0080-2024. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.