Why it was recalled
Super-Potent Drug: Out of specification for potency results (high) were obtained for one lot of morphine sulfate Inj.
Product description
Morphine Sulfate 0.5 mg/mL, Preservative Free in 0.9% Sodium Chloride, Rx, total volume 1 mL, This is a compounded drug, CII, IV Use, syringe, Pharmakon Pharmaceuticals, NDC 45183-0322-78.
Lot numbers, UPCs & expiration codes
Lot #: E52418EV11C, Exp 03/19/2016
Where it was sold
IN and IL
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-0871-2016
- Classification
- Class I
- Status
- Terminated
- Recall initiated
- Feb 11, 2016
- FDA report date
- Jun 1, 2016
- Quantity
- 75 Syringes
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Pharmakon Pharmaceuticals
Original FDA data
Every field from FDA enforcement report D-0871-2016, exactly as published.
Show all FDA fields
- City
- Noblesville
- State
- IN
- Status
- Terminated
- Country
- United States
- Event ID
- 73297
- Address
- 14450 Getz Rd
- Code information
- Lot #: E52418EV11C, Exp 03/19/2016
- Postal code
- 46060-3303
- Report date
- Jun 1, 2016
- Product type
- Drugs
- Recall number
- D-0871-2016
- Classification
- Class I
- Recalling firm
- Pharmakon Pharmaceuticals
- Product quantity
- 75 Syringes
- Termination date
- May 16, 2017
- Reason for recall
- Super-Potent Drug: Out of specification for potency results (high) were obtained for one lot of morphine sulfate Inj.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Morphine Sulfate 0.5 mg/mL, Preservative Free in 0.9% Sodium Chloride, Rx, total volume 1 mL, This is a compounded drug, CII, IV Use, syringe, Pharmakon Pharmaceuticals, NDC 45183-0322-78.
- Distribution pattern
- IN and IL
- Recall initiation date
- Feb 11, 2016
- Initial firm notification
- Telephone
- Center classification date
- May 25, 2016