Why it was recalled
Sub-potent Drug; firm's analysis revealed subpotent result for morphine sulfate assay.
Product description
Morphine Sulfate, 2 mg per mL (60 mg per 30 mL) 30 mL total volume in a 35 mL Monoject Barrel Syringes in Sodium Chloride 0.9%, Rx only, Contains Sulfites, Compounded Drug, Not for Resale, Hospital/Office Use only, IV use only, NDC 61553-401-44.
Lot numbers, UPCs & expiration codes
Lot #:151370066M, Exp. 08/15/2015
Where it was sold
WI
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-0658-2016
- Classification
- Class I
- Status
- Terminated
- Recall initiated
- May 22, 2015
- FDA report date
- Feb 17, 2016
- Quantity
- 19 Syringes
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Pharmedium Services, LLC
Original FDA data
Every field from FDA enforcement report D-0658-2016, exactly as published.
Show all FDA fields
- City
- Lake Forest
- State
- IL
- Status
- Terminated
- Country
- United States
- Event ID
- 72478
- Address
- 150 N Field Dr Ste 350
- Code information
- Lot #:151370066M, Exp. 08/15/2015
- Postal code
- 60045-2506
- Report date
- Feb 17, 2016
- Product type
- Drugs
- Recall number
- D-0658-2016
- Classification
- Class I
- Recalling firm
- Pharmedium Services, LLC
- Product quantity
- 19 Syringes
- Termination date
- Feb 18, 2016
- Reason for recall
- Sub-potent Drug; firm's analysis revealed subpotent result for morphine sulfate assay.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Morphine Sulfate, 2 mg per mL (60 mg per 30 mL) 30 mL total volume in a 35 mL Monoject Barrel Syringes in Sodium Chloride 0.9%, Rx only, Contains Sulfites, Compounded Drug, Not for Resale, Hospital/Office Use only, IV use only, NDC 61553-401-44.
- Distribution pattern
- WI
- Recall initiation date
- May 22, 2015
- Initial firm notification
- Telephone
- Center classification date
- Feb 10, 2016