Class II · Moderate risk Terminated
GLYCOpyrrolate (PF) 1 mg/5 mL (0.2 mg/mL) 5 mL Fill in a 6 mL Single Dose Syringe, Rx Only, KRS Global Biotechnology 791 Park of…
Reason Lack of Assurance of Sterility
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 Terminated
GLYCOpyrrolate (PF) 0.6 mg/3 mL (0.2 mg/mL) in 3 mL Single Dose Syringe, Rx Only, KRS Global Biotechnology 791 Park of Commerce…
Reason Lack of Assurance of Sterility
Class II · Moderate risk Terminated
Glycopyrrolate 0.6 mg/3 mL (0.2 mg per mL) Injectable Solution, 3 mL Sterile single use syringe, For IV or IM use, NDC…
Reason Lack of Assurance of Sterility
Class II · Moderate risk Terminated
Glycopyrrolate Injectable Solution 1 mg/5 mL (0.2 mg per mL), Sterile single use syringe, NDC: 42852-828-67 Avella of Houston…
Reason Lack of Assurance of Sterility
Class II · Moderate risk Terminated
Glycopyrrolate 0.2 mg/mL 2ml. Rx Only. Packaged in 2 mL syringes. Compounded Guardian Pharmacy Services, 7920 Elmbrook Dr. Ste…
Reason Lack of sterility assurance.
Class II · Moderate risk Terminated
Glycopyrrolate in all strengths, all doses, and all packaging.
Reason Lack of sterility assurance.
Class II · Moderate risk Terminated
Glycopyrrolate Injection Solution, 1 mL 0.2 mg/1 mL (0.2 mg/mL) Single-Dose Syringe, Rx Only, Cantrell Drug Company 7321 Cantrell…
Reason Lack of Sterility Assurance.
Class II · Moderate risk Terminated
Glycopyrrolate Injection Solution, 2 mL 0.4 mg/2 mL (0.2 mg/mL) Single-Dose Syringe, Rx Only, Cantrell Drug Company 7321 Cantrell…
Reason Lack of Sterility Assurance.
Class II · Moderate risk Terminated
Glycopyrrolate Injection Solution, 5 mL 1 mg/5 mL (0.2 mg/mL) Single-Dose Syringe, Rx Only, Cantrell Drug Company 7321 Cantrell…
Reason Lack of Sterility Assurance.
Class II · Moderate risk Terminated
Glycopyrrolate all strengths, all dosage forms and all packaging, Rx Only, Avella of Houston, Houston, TX 77054
Reason Labeling: Not Elsewhere Classified: Products may contain synthetic latex and/or natural latex.
Class II · Moderate risk Terminated
Glycopyrrolate 1 mg/5 mL (0.2 mg/mL) Injection Solution, 5 mL Single-Dose Syringe, For IV Use, Hospital/Office Use Only, Rx Only…
Reason Lack of Assurance of Sterility - the firm is recalling select sterile drug products.
Class II · Moderate risk Terminated
Glycopyrrolate USP ( 1 mg/5 mL), 5 mL Single Use syringe, For IM or IV Injection, Rx only, Compounded by US Compounding…
Reason Lack of Assurance of Sterility; The firm is recalling all sterile preparations that are within expiry due to deficient practices which may have an…
Class II · Moderate risk Terminated
Glycopyrrolate 0.2 mg/mL, injectable packed in syringes, Total dosage 1 mg/ 5mL, Rx only, PHARMAKON Pharmaceuticals, Inc.
Reason Stability data does not support expiry.
Class II · Moderate risk Terminated
GLYCOPYRROLATE, Injectable Solution, 0.2 mg/mL, 300 mL syringe, Rx only, JD & SN Inc, DBA Moses Lake Professional Pharmacy, 1555…
Reason Lack of Assurance of Sterility; all sterile human compounded drugs within expiry
Class II · Moderate risk Terminated
glycopyrrolate, 0.2 mg per mL, 1 mg per 5 mL, 5 mL Total Volume in a syringe, For IV Use, Rx only, PharMEDium, Product code…
Reason Stability Data Does Not Support Expiry: potential loss of potency in drugs packaged and stored in syringes.
Class II · Moderate risk Terminated
glycopyrrolate, 0.2 mg per mL, 0.4 mg per 2 mL, 2 mL Total Volume in a syringe, For IV Use, Rx only, PharMEDium, Product code…
Reason Stability Data Does Not Support Expiry: potential loss of potency in drugs packaged and stored in syringes.
Class II · Moderate risk Terminated
glycopyrrolate, 0.2 mg per mL, 0.6 mg per 3 mL, 3 mL Total Volume in a syringe, For IV Use, Rx only, PharMEDium, Product code…
Reason Stability Data Does Not Support Expiry: potential loss of potency in drugs packaged and stored in syringes.
Class II · Moderate risk Terminated
Glycopyrrolate 0.2 mg/1 mL Susp (Robinul), Health Innov Pharmacy, 295 Pinehurst Ave, Southern Pines, NC 28387, (910) 246-5155
Reason Lack of Assurance of Sterility and Stability Data does not Support Expiry: recent inspection observations associated with certain quality control…
Class II · Moderate risk Terminated
Glycopyrrolate injection, 0.2 mg per mL (1 mg/5 mL), 5 mL Fill in 10 mL Syringe, Rx Only, SCA Pharmaceuticals, 8821 Knoedl Ct…
Reason Labeling: Incorrect or missing Lot and/or Exp Date: Printing error caused an overlap in the "y" and "3" making the actual "Use By 3/2015" date appear…
Class II · Moderate risk Terminated
Glycopyrrolate 0.2 mg/ml, 5 mL pre-filled syringe, Rx Only. Pharmakon Pharmaceuticals, Inc., 14450 Getz Rd., Noblesville, IN…
Reason Incorrect/ Undeclared Excipient: Contains undeclared benzyl alcohol.
Class I · High risk Terminated
Glycopyrrolate (MDV) 0.2 MG/ML Injectable, 5 mL Vials, Sterile Serum Vials/Sterile Syringes, for use by a licensed professional…
Reason Non-Sterility: One lot of Glycopyrrolate solution for injection was found to be contaminated with Bacillus thuringiensis.
Class II · Moderate risk Terminated
GLYCOPYRROLATE, Tablet, 2 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00603318121.
Reason Labeling: Label Mixup: GLYCOPYRROLATE, Tablet, 2 mg may have potentially been mislabeled as one of the following drugs: PARICALCITOL, Capsule, 1…
Class II · Moderate risk Terminated
GLYCOPYRROLATE Tablet, 2 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 49884006601
Reason Labeling: Label Mixup; GLYCOPYRROLATE Tablet, 2 mg may be potentially mislabeled as LACTOBACILLUS, Tablet, NDC 64980012950, Pedigree: W003624…
Class III · Low risk Terminated
Glycopyrrolate Tablets, USP, 1 mg, Rx Only, 100 tablets per bottle, Manufactured by: West-ward Pharmaceutical Corp., Eatontown…
Reason Subpotent Drug
Get an alert if your medication is recalled
Tell us which medications you take. If the FDA recalls one, we email you - in plain English, with what to do. Free.