Phenylephrine Injectable Drug Recalled for Lack of Sterility Assurance
SCA Pharmaceuticals is recalling phenylephrine HCl injection syringes nationwide due to inability to assure sterility. Patients using recalled lots should contact their healthcare provider.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is an FDA Class II recall of an injectable product with potential for serious harm due to sterility concerns, but no reported illnesses or injuries. Per the rubric, theoretical-hazard recalls with no reported illness are limited to score 3 (High).
Plain-English summary
SCA Pharmaceuticals is recalling phenylephrine HCl 500 mcg/5 mL injection in 0.9% sodium chloride in pre-filled syringes. The recall is nationwide and affects approximately 7,198 syringes, with an additional 1,289 syringes under expanded recall. This is a prescription-only medication (NDC 70004-0810-11).
The recall is due to lack of assurance of sterility. The affected lots are: 1223045053 (exp. 11/15/23), 1223046179 (exp. 12/28/23), 1223047477 (exp. 02/16/24), 1223047602 (exp. 02/22/24), 1223047971 (exp. 03/14/24), 1223048269 (exp. 03/27/24), and expanded lot 1223048181 (exp. 03/22/24).
Patients should contact their healthcare provider if they received injections from these lots. Healthcare providers should verify lot numbers against the FDA recall notice. Any unused product from the affected lots should not be used.
The recalled product
- Product
- PHENYLephrine HCl 500 mcg/5 mL in 0.9% Sodium Chloride Injection, (Concentration = 100 mcg/mL), 5 mL fill 12 mL Syringe, Rx Only, SCA Pharmaceuticals, 755 Rainbow Rd. Windsor, CT 06095, NDC 70004-0810-11, Bar Code 70004081011
- Manufacturer
- SCA Pharmaceuticals, LLC
- Category
- Drug — Injectable
- Hazard
- sterility-assurance
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 #: 1223045053 Exp 11/15/23
- 1223046179 Exp 12/28/23
- 1223047477 Exp 02/16/24
- 1223047602 Exp 02/22/24
- 1223047971 Exp 03/14/24
- 1223048269 Exp 03/27/24 Expanded lot#: 1223048181
- exp. date 03/22/2024
Distribution
Distributed nationwide across the United States.
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