Phenylephrine HCl syringe recalled for manufacturing practice deviations
Phenylephrine HCl syringe recalled for manufacturing practice deviations. 13,445 units distributed nationwide were recalled by Denver Solutions, LLC.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: FDA Class II recall for manufacturing practice deviations with no reported illnesses or injuries. The firm initiated the recall voluntarily as a precautionary measure and the recall was later terminated.
Plain-English summary
Denver Solutions, LLC, operating as Leiters Health, is recalling 13,445 units of Phenylephrine HCl 0.5 mg per 5 mL (100 mcg/mL) in 5 mL syringes, NDC 71449-001-11. This prescription medication was distributed nationwide, including to government facilities.
The firm initiated this voluntary recall on February 21, 2023, due to Current Good Manufacturing Practice (CGMP) deviations discovered at the manufacturing facility. The affected product lots are numbered 2230960 (expiration March 12, 2023) and 2231080 (expiration April 9, 2023).
If you have received product from these lots, contact the firm or the FDA for return guidance. The recall was terminated on January 11, 2024, after the manufacturing issue was resolved.
The recalled product
- Product
- Phenylephrine HCl 0.5 mg per 5 mL (100 mcg/mL), 5 mL Syringe, Rx only, Leiters 13796 Compark Blvd Englewood CO 80112, NDC 71449-001-11
- Manufacturer
- Denver Solutions, LLC DBA Leiters Health
- Category
- Drug — Prescription Injectable
- Hazard
- cgmp-deviation
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 (4)
- Lot #: 2230960
- Exp date 3/12/2023
- 2231080
- Exp date 4/9/2023.
Distribution
Distributed nationwide across the United States.
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