Phenylephrine HCl Injections Recalled Nationwide for Sterility Assurance Issues
SCA Pharmaceuticals is recalling Phenylephrine HCl injections nationwide affecting approximately 33,000 units due to lack of assurance of sterility.
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 for a risk-of-harm injectable product with sterility concerns. No illnesses, injuries, or hospitalizations are reported in the source, and the hazard remains theoretical, which limits the score to 3 per the rubric.
Plain-English summary
SCA Pharmaceuticals, LLC is recalling Phenylephrine HCl 1000 mcg/10 mL injections distributed nationwide in 10 mL prefilled syringes (NDC 70004-0810-12). The recall was initiated due to lack of assurance of sterility.
Approximately 33,072 syringes were distributed, with an expanded recall of an additional 9,041 units. The affected lots span multiple batches with expiration dates from December 2023 through June 2024.
Healthcare facilities should check their inventory for affected lots and quarantine these units. Patients who have received this medication should contact their healthcare provider to discuss potential concerns related to the sterility assurance issue.
The recalled product
- Product
- PHENYLephrine HCl 1000 mcg/10 mL in 0.9% Sodium Chloride Injection, (Concentration = 100 mcg/mL), 10 mL fill 12 mL Syringe, Rx Only, SCA Pharmaceuticals, 755 Rainbow Rd. Windsor, CT 06095, NDC 70004-0810-12, Bar Code 70004081012
- Manufacturer
- SCA Pharmaceuticals, LLC
- Category
- Drug — Injectable Medication
- Hazard
- 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 (19)
- Lot #: 1223045536 Exp 12/06/23
- 1223045710 Exp 12/10/23
- 1223046574 Exp 01/12/24
- 1223047579 Exp 02/21/24
- 1223047764 Exp 03/06/24
- 1223048363 Exp 03/30/24
- 1223048364 Exp 03/30/24
- 1223048566 Exp 04/06/24
- 1223048573 Exp 04/07/24
- 1223048574 Exp 04/07/24
- 1223048643 Exp 04/11/24
- 1223048697 Exp 04/12/24
- 1223048742 Exp 04/13/24 Expanded lots#: 1223048065
- Exp 04/06/2024
- 1223048395
- 1223048397
- Exp 03/27/2024
- 1223049980
- Exp 06/05/2024
Distribution
Distributed nationwide across the United States.
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