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.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. 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
- Affected units
- 8
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:
Part of a larger recall action
This product is one of 12 recalled by Family Pharmacy of Statesville under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 12 products in this recall →Related recalls
Same manufacturer · Family Pharmacy of Statesville
See all →- SevereHydromorphone HCl 1 mg/mL 250 mL Bags Recalled for Lack of Sterility Assurance
FDA (Drugs) · 2022-03-23
- SevereTrimix Injectable Vials Recalled for Lack of Sterility Assurance
FDA (Drugs) · 2022-03-23
- SevereMethylcobalamin Injectable Recalled Due to Lack of Sterility Assurance
FDA (Drugs) · 2022-03-23
- SevereKetamine 50 mg Infusion Solution Recalled for Lack of Sterility Assurance
FDA (Drugs) · 2022-03-23
- HighTrimix Injectable Vials Recalled for Lack of Sterility Assurance
FDA (Drugs) · 2022-03-23
Same hazard · sterility failure
See all →- SevereAvKare Carboxymethylcellulose Sodium Eye Drops Recalled for Sterility Concerns
FDA (Drugs) · 2026-09-30
- SevereAvKare Carboxymethylcellulose Sodium Eye Drops Recalled for Sterility Concerns
FDA (Drugs) · 2026-09-30
- SevereROHTO DIGI-EYE Eye Drops Recalled Over Sterility Assurance Gap
FDA (Drugs) · 2026-07-29
- HighROHTO DRY-AID Eye Drops Recalled Due to Sterility Concerns
FDA (Drugs) · 2026-07-29
- SevereOne-Piece Introducer Tray kits recalled for sterility failure
FDA (Devices) · 2026-07-22
Similar recalls
- HighMorphine Sulfate Intravenous Solutions Recalled Due to Sterility Assurance Failure
FDA (Drugs) · 2023-02-22
- SeverePharmakon Recalls Morphine Sulfate Syringes Due to Sterility Concerns
FDA (Drugs) · 2016-07-20
- HighMorphine Sulfate Injection Recalled Due to Sterility Assurance Concerns
FDA (Drugs) · 2022-07-27
- SeverePharmakon Recalls Morphine Sulfate Bags Due to Sterility Concerns
FDA (Drugs) · 2016-07-20
- SevereSterRx Morphine Sulfate Injection Recalled for Sterility Assurance
FDA (Drugs) · 2022-01-05
- HighMorphine Sulfate Injection Recalled Due to Lack of Sterility Assurance
FDA (Drugs) · 2022-07-27