Glycopyrrolate Injection
Presence of Particulate Matter: Hair was found in product
Class III — Low risk. Unlikely to cause harm, but violates FDA regulations.
Labeling: Label Mix-up
Cause type: Labeling / mix-up
Wrong label, wrong strength, mixed-up products, or packaging errors. One of the most dangerous causes - you can end up taking the wrong drug or the wrong dose. All labeling / mix-up recalls.
GLYCOPYRROLATE INJECTION, USP 0.2MG/ML, 1mL VIAL, manufactured by HF Acquisition Co. LLC, Mukilteo, WA 98275, NDC 51662-1487-3
Compare with the code on your package — it is the most precise check available.
Drug: Glycopyrrolate
From the FDA NDC directory, for the product code this recall names. Compare with the label on your package.
| Product | Strength | Form & route | Labeler | Type |
|---|---|---|---|---|
| Glycopyrrolate NDC 51662-1487 |
.2 mg/mL | Injection Intramuscular|intravenous |
HF Acquisition Co LLC, DBA HealthFirst | Rx |
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.
Presence of Particulate Matter: Hair was found in product
Failed Impurities/Degradation Specifications
Failed Impurities/Degradation Specifications
Lack of Assurance of Sterility: Leaking/damaged syringes.
Lack of assurance of sterility. Validation data for decontamination cycles is lacking.
TEMPERATURE ABUSE: Complaint received from customer that product was received in a non-refrigerated state.
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