Class II · Moderate risk
Glycopyrrolate Injection
Presence of Particulate Matter: Hair was found in product
Glycopyrrolate Injection
Class III — Low risk. Unlikely to cause harm, but violates FDA regulations.
Why it was recalled
Failed Impurities/Degradation Specifications
Cause type: Impurity / degradation
An impurity or degradation product above its limit - other than nitrosamines. Unexpected substances in a batch can make it unsafe or less effective, even when the active ingredient is present. All impurity / degradation recalls.
What was recalled
Glycopyrrolate Injection, USP 4mg per 20mL, 20 mL Multi-Dose Vials, Rx only, Mfd for Meitheal Pharmaceuticals, Chicago, IL 60631. NDC 71288-408-21
Affected NDC
71288-0408-21
Compare with the code on your package — it is the most precise check available.
Drug: Glycopyrrolate
- Recalling firm
- Meitheal Pharmaceuticals Inc
- NDC code
- 71288-408-21
- Origin
- IL, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0801-2021 · FDA notice
Low risk, still worth a check. Class III means the product is unlikely to cause harm but breaks an FDA rule (often labeling). If your lot matches, your pharmacy will normally swap it; there is no need for alarm. This recall is now terminated, which means the firm has finished removing the affected product; anything on pharmacy shelves today should be unaffected.
Other Glycopyrrolate recalls
See all
Class II · Moderate risk
Glycopyrrolate Oral Solution
Failed Impurities/Degradation Specifications
Class III · Low risk
Glycopyrrolate Oral Solution
Failed Impurities/Degradation Specifications
Class II · Moderate risk
Glycopyrrolate
Lack of Assurance of Sterility: Leaking/damaged syringes.
Class II · Moderate risk
glycopyrrolate 1 mg/5 mL
Lack of assurance of sterility. Validation data for decontamination cycles is lacking.
Other recalls by Meitheal Pharmaceuticals Inc
All 2021 recalls
Class II · Moderate risk
Cetrorelix Acetate for Injection
Defective Delivery System: Missing or duplicated needles within the injection kit
Class I · High risk
Cisatracurium Besylate Injection
Labeling: Label mix-up: Carton of Cisatracurium Besylate Injection, USP was observed to contain ten vials mislabeled as Phenylephrine Hydrochloride Injection, USP, but confirmed to contain Cisatracurium
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