SCA Pharmaceuticals Recalls Norepinephrine Bags Due to Sterility Concerns
SCA Pharmaceuticals is voluntarily recalling specific lots of Norepinephrine Bitartrate bags due to a potential for leakage that compromises sterility.
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: The recall is classified as FDA Class II, which corresponds to a Severe rating under the rubric, particularly given the risk of infection from non-sterile medical products.
Plain-English summary
SCA Pharmaceuticals, LLC is conducting a voluntary recall of certain lots of Norepinephrine Bitartrate 4 mg (16 mcg/mL) in 0.9% Sodium Chloride 250 mL bags. The recall is being issued due to a lack of assurance of sterility resulting from a potential for leakage in the packaging.
The affected product includes 2,268 bags from specific lots with expiration dates ranging from June 19, 2018, to July 3, 2018. The product was distributed throughout the United States.
Healthcare facilities and consumers should stop using the affected lots immediately and contact SCA Pharmaceuticals or their supplier for instructions on return or disposal.
The recalled product
- Product
- Norepinephrine Bitartrate 4 mg (16 mcg/mL) in 0.9% Sodium Chloride 250 mL bag, SCA Pharmaceuticals, LLC, Windsor, CT
- Manufacturer
- SCA Pharmaceuticals, LLC
- Category
- Drug — Sterile Admixtures
- Affected units
- 2,268
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 (7)
- Lot # 1218000928
- 1218000944
- 1218000945
- 1218001075
- 1218001076
- 1218001188
- Exp 06/19/2018-07/03/2018
Distribution
Distribution scope not specified by the agency.
Part of a larger recall action
This product is one of 12 recalled by SCA Pharmaceuticals, LLC 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 · SCA Pharmaceuticals, LLC
See all →- HighPhenylephrine HCl Injections Recalled Nationwide for Sterility Assurance Issues
FDA (Drugs) · 2024-04-03
- HighInjectable midazolam HCl recalled due to sterility assurance failure
FDA (Drugs) · 2024-04-03
- HighFentanyl and Bupivacaine Epidural Injection Recalled for Sterility Assurance Issue
FDA (Drugs) · 2024-04-03
- HighHydromorphone Injection Recalled Due to Lack of Sterility Assurance
FDA (Drugs) · 2024-04-03
- HighHYDROmorphone HCl 6 mg Injectable Syringes Recalled Due to Sterility Assurance Issues
FDA (Drugs) · 2024-04-03
Same hazard · sterility
See all →- SevereRegeneron Recalls Libtayo Injection Due to Sterility Assurance Concerns
FDA (Drugs) · 2026-08-26
- SeverePrestige Recalls Clear Eyes Maximum Itchy Eye Relief Due to Sterility Concerns
FDA (Drugs) · 2026-08-19
- SevereROHTO Cooling Eye Drops Recalled Over Sterility Assurance Concerns
FDA (Drugs) · 2026-07-29
- HighROHTO Cooling Eye Drops Recalled Over Sterility Assurance Concerns
FDA (Drugs) · 2026-07-29
- SevereFDA Recalls ROHTO OPTIC GLOW Eye Drops Over Sterility Concerns
FDA (Drugs) · 2026-07-29