Compounded phenylephrine syringes recalled over current good manufacturing practice deviations
Park Avenue Compounding is recalling 858 syringes of Phenylephrine HCl, 1000 mcg / 10 mL, over current good manufacturing practice deviations.
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: Scored 2 because the record cites current good manufacturing practice deviations with no stated product defect or reported harm.
Plain-English summary
Phenylephrine HCl, 1000 mcg / 10 mL, in a 10 mL total volume syringe, prescription only, from Park Avenue Compounding of Saint Louis, Missouri, under NDC 83863-0104-1, is being recalled.
The reason given in the enforcement record is CGMP deviations.
The recall covers 858 syringes from lot 20250813-13D65E, expiry FEB-09-2026. Distribution was in Missouri. The FDA has classified the action as Class II.
The record cites manufacturing practice deviations without describing a specific product defect, and states no injuries. Facilities should follow the firm's instructions.
The recalled product
- Product
- Phenylephrine HCI, 1000 mcg / 10 mL, 10 mL Total Volume, Rx Only, Park Avenue Compounding, 3662 Park Ave, Saint Louis, MO, 63110-2512, NDC 83863-0104-1.
- Manufacturer
- Park Avenue Compounding
- Category
- Drug — Compounded injectable
- Hazard
- cgmp-deviation
- compounding
- manufacturing-quality
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 (2)
- Lot # 20250813-13D65E
- Exp Date: FEB-09-2026.
Distribution
Distributed in 1 state:
- MO
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