Park Avenue Compounding recalled 858 syringes of Phenylephrine HCI on September 17, 2025, due to CGMP deviations. The recall affects syringes with Lot # 20250813-13D65E and an expiration date of February 9, 2026. Consumers must stop using the product immediately and consult healthcare providers for further guidance.
CGMP Deviations
Consumers and healthcare providers should stop using this product immediately. Contact Park Avenue Compounding or your healthcare provider for guidance. Notification method: Letter
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The recall involves Phenylephrine HCI, 1000 mcg / 10 mL syringes. The product is sold by Park Avenue Compounding, located at 3662 Park Ave, Saint Louis, MO 63110-2512. It falls under the NDC 83863-0104-1.
The recall stems from CGMP deviations, which indicate that the product may not have been manufactured in accordance with federal regulations. This poses potential risks to consumers and healthcare providers.
As of now, there have been no reported incidents or injuries associated with this recall. The risk level is assessed as high due to the nature of CGMP violations.
Consumers and healthcare providers should stop using the recalled syringes immediately. Contact Park Avenue Compounding or consult your healthcare provider for additional guidance. Notification will be sent via letter.
For more information, contact Park Avenue Compounding at their address or visit the FDA recall page at https://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?recall_number=D-0200-2026.
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