Morphine Sulfate Infusion Recall Due to Sterility Assurance Failure
Family Pharmacy of Statesville is recalling Morphine Sulfate 6 mg/mL infusions in 250 mL bags due to lack of assurance of sterility. The affected product was distributed in North Carolina.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: This is an FDA Class II recall of a sterile pharmaceutical product where loss of sterility assurance creates risk of serious adverse outcomes including infection or sepsis. The hazard involves a critical pharmaceutical property (sterility) in an injectable medication administered to patients, warranting a Severe rating.
Plain-English summary
Family Pharmacy of Statesville, Inc. is recalling Morphine Sulfate 6 mg/mL Infusion in 250 mL bags because the pharmacy cannot assure the products maintain sterility as required.
The recalled product consists of 8 bags of morphine sulfate infusion with the following lot numbers: Lot #07212020@3 (Best Use Date 10/19/2020) and Lot #07292020@2 (Best Use Date 10/27/2020). The product is a prescription-only medication that was distributed in North Carolina.
Patients receiving this product or healthcare providers who have this medication in stock should immediately cease use and consult with the pharmacy or their healthcare provider regarding this recall. Patients should not stop taking morphine without medical guidance, as doing so may cause serious withdrawal symptoms.
The recalled product
- Product
- Morphine Sulfate 6 mg/mL Infusion in 250 mL bag, Rx only, Family Pharmacy of Statesville, Inc.
- Manufacturer
- Family Pharmacy of Statesville
- Category
- Drug — Injectable / Infusion
- Hazard
- sterility-failure
- contamination-risk
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- Lot #: 07212020@3 BUD: 10/19/2020
- 07292020@2 BUD: 10/27/2020
Distribution
Distributed in 1 state:
- NC
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