The Recall Desk

Hazard

Manufacturing Control Failure recalls

4 recalls in our database tag this hazard, drawn from FDA, USDA FSIS, CPSC, and NHTSA source notices.

What the numbers show

Total
4
Critical
0
Severe
0
Most recent
2022-09-14

Of the 4 manufacturing control failure recalls we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 0 (0%) are Severe.

About this hazard tag

Hazard tags are short, machine-readable labels we attach to every recall to make cross-cutting queries possible — “all manufacturing control failure recalls regardless of agency”, “all listeria recalls in California”, “all airbag recalls in 2025”. The tags are extracted from each recall’s source text during the LLM rewrite step and validated against a fixed schema.

A recall can carry multiple tags — a Listeria recall might also be tagged ready-to-eat and undeclared-allergen. Use the full-text search if you want to combine hazard tags with brand or category filters.

1–4 of 4

  • HighFDA (Drugs)·D-1491-2022·2022-09-14

    Guaifenesin and Dextromethorphan Cough Syrup Recalled for Manufacturing Control Deviations

    Plastikon Healthcare LLC is recalling Guaifenesin and Dextromethorphan cough syrup cups distributed nationwide due to manufacturing processes that were not adequately controlled.

    Product
    GUAIFENESIN AND DEXTROMETHORPHAN 200-20 mg/10 mL, 10 mL cup, packaged in 10 cups per tray, 10 trays per carton, For Institutional Use Only, Major Pharmaceuticals, 17177 N Laurel Park Dr. Suite 233, Livonia, MI 48152, NDC 0904-6980-72
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1483-2022·2022-09-14

    Magnesium Hydroxide and Aluminum Hydroxide Oral Suspension Recalled for Manufacturing Control Issues

    Plastikon Healthcare LLC is recalling an antacid oral suspension due to manufacturing control deviations. No illnesses have been reported.

    Product
    Magnesium Hydroxide 2400 mg, Aluminum Hydroxide 2400 mg, Simethicone 240 mg MAX, per 30 mL Oral Suspension, 30 mL cup, packaged in 10 cups per tray, 10 trays per carton, For Institutional Use Only, Major Pharmaceuticals, 17177 N Laurel Park Dr., Suite 233, Livonia, MI 48152, NDC
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0801-2022·2022-05-04

    Olympia Compounding Pharmacy Recalls AT-6 Injectable Drug Due to Manufacturing Control Deviations

    Olympia Compounding Pharmacy is recalling AT-6 injectable drug due to manufacturing facility control failures. Environmental and personnel monitoring deviations were not properly investigated prior to October 2021.

    Product
    AT-6, Papaverine 40mg/ml . Phentolamine 4mg/ml . Atropine 0.3mg/ml, Multi-Dose 10 ml vial, Rx Only, Olympia Pharmaceuticals 6700 Convoy Rd., Ste. 155, Orlando, FL 32835. NDC 73198-0040-10
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0803-2022·2022-05-04

    Compounded Injectable Drug Recalled for Manufacturing Control Failures

    Olympia Compounding Pharmacy is recalling NB-243, a compounded injectable medication, due to manufacturing control failures. Environmental and personnel monitoring excursions were not properly investigated prior to October 2021.

    Product
    NB-243, Papaverine 30mg/ml . Phentolamine 3mg/ml . Alprostadil 20mcg/ml, 10ml Multi-Dose vials, Rx Only, Olympia Pharmaceuticals 6700 Convoy Rd., Ste. 155, Orlando, FL 32835. NDC 73198-0009-10
    Category
    Drug
    Distribution
    Distributed nationwide