Class II · Moderate risk Ongoing
Glycopyrrolate Injection, USP, 1 mg per 5 mL (0.2 mg per mL), 25 x 5 mL fill in a 6.5 mL vial, Rx only, Multiple Dose Vials…
Reason Presence of Particulate Matter: Hair was found in product
Is Glycopyrrolate recalled?
49 FDA recalls mention Glycopyrrolate. The most recent are listed below.
Recalls are matched by product description. A recall usually affects specific lots, not every package of Glycopyrrolate.
Class II · Moderate risk Ongoing
Glycopyrrolate Oral Solution, 1 mg/5 mL, delivers 5 mL, Rx only, Pkg: Precision Dose, Inc, S. Beloil, IL 61080, unit-dose oral…
Reason Failed Impurities/Degradation Specifications
Class III · Low risk Ongoing
Glycopyrrolate Oral Solution, 1 mg/5 mL, 16 oz. (473 mL), Rx only, Manufactured by: MSN Pharmaceuticals Inc., Piscataway, NJ…
Reason Failed Impurities/Degradation Specifications
Class II · Moderate risk Ongoing
Glycopyrrolate, 1mg per 5mL, (0.2 mg/mL), Single Dose 5 mL syringe, Rx only, Leiters Health, 13796 Compark Blvd, Englewood, CO…
Reason Lack of Assurance of Sterility: Leaking/damaged syringes.
Class II · Moderate risk Terminated
glycopyrrolate 1 mg/5 mL (0.2 mg/mL), For Anesthesia Use, Syringe, RX ONLY, CAPS, Inc., 2200 South 43rd Avenue, Phoenix, AZ…
Reason Lack of assurance of sterility. Validation data for decontamination cycles is lacking.
Class III · Low risk Terminated
GLYCOPYRROLATE INJECTION, USP 0.2MG/ML, 1mL VIAL, manufactured by HF Acquisition Co. LLC, Mukilteo, WA 98275, NDC 51662-1487-3
Reason Labeling: Label Mix-up
Class III · Low risk Terminated
Glycopyrrolate Tablets, USP, 1 mg, 100-count bottles, Rx Only, Distributed by: Aurobindo Pharma USA, Inc., East Windsor, NJ…
Reason Failed Impurities/Degradation Specifications
Class II · Moderate risk Terminated
Glycopyrrolate Injection, USP 4 mg/20 mL (0.2 mg/mL) 20 mL Multiple Dose Vial, 10vial carton, Rx Only, Manufactured for: Accord…
Reason CGMP Deviations: recalling drug products following an FDA inspection.
Class II · Moderate risk Terminated
Glycopyrrolate Injection, USP 1 mg/5 mL (0.2 mg/mL) 5 mL Multiple Dose Vial, x 10 vials carton, Rx Only, Manufactured for: Accord…
Reason CGMP Deviations: recalling drug products following an FDA inspection.
Class II · Moderate risk Terminated
Glycopyrrolate Injection, USP, 0.4 mg/2 mL (0.2 mg/mL) 2 mL Single Dose Vial X 25 vials carton, Rx Only, Manufactured for: Accord…
Reason CGMP Deviations: recalling drug products following an FDA inspection.
Class II · Moderate risk Terminated
Glycopyrrolate Injection, USP, 0.2 mg/mL, 1 mL Single Dose Vial x 25 vials, Rx Only, Manufactured for: Accord Healthcare, Inc…
Reason CGMP Deviations: recalling drug products following an FDA inspection.
Class II · Moderate risk Completed
Glycopyrrolate Tablets, USP, 1 mg, 50 Tablets (5x10) Unit Dose carton, Rx Only, Manufactured for: AvKARE Pulaski, TN 38478, NDC…
Reason Failed impurities/degradation specifications: Out of specification for unknown impurities.
Class II · Moderate risk Ongoing
Glycopyrrolate Tablets, USP, 1 mg, 100 tablets, Rx Only, Distributed by: Aurobindo Pharma USA, Inc., East Windsor, NJ 08520, NDC…
Reason Failed Impurities/Degradation Specifications
Class II · Moderate risk Terminated
Glycopyrrolate Injection, USP, 0.6 mg/3 mL (0.2 mg/mL) syringes, packaged in 5 x 3 mL Pre-Filled Syringes per carton, 6 x 5…
Reason Lack of Assurance of Sterility
Class II · Moderate risk Terminated
Glycopyrrolate Injection, USP, 1 mg/5 mL (0.2 mg/mL) syringes, packaged in 5 x 5 mL Pre-Filled Syringes per carton, 6 x 5 Syringe…
Reason Lack of Assurance of Sterility
Class II · Moderate risk Terminated
Glycopyrrolate Injection, USP, 0.6 mg/3 mL (0.2 mg/mL), Preservative Free, 3 mL Pre-Filled Syringe, 5 x 3 mL Pre-Filled Syringes…
Reason Lack of Assurance of Sterility
Class II · Moderate risk Terminated
Glycopyrrolate Injection, USP, 1 mg/5 mL (0.2 mg/mL), Preservative Free, 5 mL Pre-Filled Syringe, 5 x 5 mL Pre-Filled Syringes, 6…
Reason Lack of Assurance of Sterility
Class II · Moderate risk Terminated
Glycopyrrolate Tablets, USP, 1 mg, 100-count bottle, Rx Only, Distributed by: Aurobindo Pharma USA, Inc., 279…
Reason Presence of Foreign Substance: Complaint for pieces of glass discovered in a sealed bottle which came from equipment within the packaging room.
Class III · Low risk Terminated
Glycopyrrolate Injection, USP 4mg per 20mL, 20 mL Multi-Dose Vials, Rx only, Mfd for Meitheal Pharmaceuticals, Chicago, IL 60631…
Reason Failed Impurities/Degradation Specifications
Class II · Moderate risk Terminated
Bevespi Aerosphere (glycopyrrolate and formoterol fumarate) Inhalation Aerosol 9 mcg/4.8 mcg per inhalation For Oral Inhalation…
Reason CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Class III · Low risk Terminated
Glycopyrrolate Injection, USP 0.4 mg/2 mL (0.2 mg/mL) 25 x 2 mL Single Dose Vials Rx Only, Manufactured for: Accord Healthcare…
Reason Labeling; Label Mix-up; correctly labeled 2 mL vials were packaged into blister strips labeled for 1 mL vials
Class II · Moderate risk Terminated
Glycopyrrolate 1 mg/5mL (0.2mg/mL), 5 mL Single Dose Syringe, Rx Only, SCA Pharmaceuticals, 755 Rainbow Rd., Windsor, CT…
Reason Lack of Assurance of Sterility; potential for a defective syringe cap, resulting in a non-integral unit
Class II · Moderate risk Terminated
Glycopyrrolate Tablets, USP 1 mg, 100-count bottle, Rx only, Dist. by: Par Pharmaceutical, Chestnut Ridge, NY, 10977, U.S.A, Mfg…
Reason Failed Impurities/Degradation Specification: Presence of unknown impurity observed.
Class III · Low risk Terminated
Glycopyrrolate Injection, USP 4 mg per 20 mL (0.2 mg/mL), 20 mL Multiple Dose Vial, Rx Only, For Intramuscular or Intravenous…
Reason Failed Impurities/Degradation Specifications: elevated levels of Benzaldehyde impurity was found in investigative samples (retain samples).
Class II · Moderate risk Terminated
Glycopyrrolate Tabs, USP, 1 mg, 30-count unit dose blister card, FOR INSTITUTIONAL USE ONLY, Rx Only, Packaged by Vangard…
Reason Failed Impurities/Degradation Specification: High Out of Specification Results for Individual Unknown Impurity.
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