Drugs & medicalClass II

Park Avenue Compounding recalls Phenylephrine HCI, 1000 mcg / 10 mL, 10 mL Total Volume, Rx Only, Park Avenue Compounding, 3662 Park Ave, Saint Louis, MO, 63110-2512,…

CGMP Deviations

Read the official notice →
Date
2025-12-10
Country
United States
Brand
Park Avenue Compounding
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…
Classification
Class II
Units
MO
Category
Drugs & medical
Source
FDA · Drug

Copied automatically from the US Food and Drug Administration. Details may be shortened or out of date; the official notice is the authoritative source. Disclaimer

What to do

  1. Check the product name, strength and lot number against the official notice.
  2. Do not stop a prescribed medicine without talking to your doctor or pharmacist first.
  3. Ask the pharmacy or supplier about a replacement or refund.

General guidance from Recall Atlas. The official notice from the US Food and Drug Administration has the exact models, batch codes and remedy, and it takes priority.

More Park Avenue Compounding recalls

  1. 2025-11-26
  2. US
    Drugs & medicalClass II

    Park Avenue Compounding recalls Fentanyl citrate, 2 mcg / ml / Ropivacaine, 0.2% in NS 150 mL, CII, 150 mL bag, Rx Only, Park Avenue Compounding, 3662 Park Ave, Saint…

    CGMP Deviations: Revised interpretation of Acceptable Quality Level (AQL) results.

    FDA · DrugPark Avenue CompoundingDistributed in MissouriOfficial notice →
All 2 Park Avenue Compounding recalls →

Other drugs & medical recalls in the United States

  1. 2025-12-10
  2. US
    Drugs & medicalClass II

    Breckenridge Pharmaceutical, Inc. recalls Duloxetine Delayed-Release Capsules, USP, 60 mg, 1000-Capsule bottles, Rx Only, Manufactured by: Towa Pharmaceuticals Europe,…

    CGMP Deviations; presence of N-nitroso-duloxetine impurity above the FDA recommended limit

    FDA · DrugBreckenridge Pharmaceutical, Inc.Nationwide within the United StatesOfficial notice →
  3. US
    Drugs & medicalClass II

    Safecor Health, LLC recalls Haloperidol Lactate Injection, 5 mg/mL, 25 x 1 mL Single-Dose Vials, Sterile, Rx only, For Intramuscular Use Only, Manufactured for: Mylan…

    Labeling: Not Elsewhere Classified:Incorrect RFID tag labels applied to product by repackaging firm.

    FDA · DrugSafecor Health, LLCDistributed in MassachusettsOfficial notice →
  4. US
  5. US
    Drugs & medicalClass III

    Glenmark Pharmaceuticals Inc., USA recalls Bisoprolol Fumarate and Hydrochlorothiazide Tablets, USP, 2.5 mg/6.25 mg, packaged as (a) 30-count bottles, NDC-68462-878-30;…

    Cross Contamination with Other Products: Testing of reserve samples showed presence of traces of ezetimibe

    FDA · DrugGlenmark Pharmaceuticals Inc., USANationwide in the USAOfficial notice →
  6. US
    Drugs & medicalClass III

    Teva Pharmaceuticals USA, Inc recalls Carton label: Testosterone Gel 1%, 2.5 grams per unit dose, CIII, 30 unit-dose packets, Rx only, Manufactured by: Actavis…

    Defective Container - A defect in the side-seal which allows leakage of product.

    FDA · DrugTeva Pharmaceuticals USA, IncU.S. NationwideOfficial notice →
  7. US
    Drugs & medicalClass II

    Cipla Limited recalls Phytonadione Injectable Emulsion, USP 10mg/mL, 10x1 mL Single-Dose Vial/carton, Rx Only, Mfd. by: Cipla Ltd. India At M/s Immacule…

    Failed Stability Specifications: Observed OOS results: eg results for colour index

    FDA · DrugCipla LimitedNationwide in the USAOfficial notice →
See all drugs & medical recalls →