Class II · Moderate risk
Glycopyrrolate Injection
Presence of Particulate Matter: Hair was found in product
Glycopyrrolate Tablets
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Why it was recalled
Presence of Foreign Substance: Complaint for pieces of glass discovered in a sealed bottle which came from equipment within the packaging room.
Cause type: Particulate / foreign matter
Visible foreign particles - glass, metal, fibers or other material - found in the product. Particles can enter from equipment wear, containers or the process, and are dangerous in injectables. All particulate / foreign matter recalls.
What was recalled
Glycopyrrolate Tablets, USP, 1 mg, 100-count bottle, Rx Only, Distributed by: Aurobindo Pharma USA, Inc., 279 Princeton-Hightstown Road, East Windsor, NJ 08520, NDC 13107-014-01.
Affected NDC
13107-0014-01
Compare with the code on your package — it is the most precise check available.
Drug: Glycopyrrolate
Product details
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 13107-0014 |
1 mg/1 | Tablet Oral |
Aurolife Pharma LLC | Rx |
- Recalling firm
- Aurolife Pharma, LLC
- NDC code
- 13107-014-01
- Origin
- NJ, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0736-2022 · FDA notice
Check, then ask. Class II means harm is possible but usually temporary or reversible. Find the lot number on your package; if it matches, ask your pharmacist about a replacement. Do not simply stop a prescribed medication on your own - the gap can be riskier than the recall. 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
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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 Aurolife Pharma, LLC
All 2022 recalls
Class III · Low risk
Glycopyrrolate Tablets
Failed Impurities/Degradation Specifications
Class II · Moderate risk
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Failed Impurities/Degradation Specifications
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Allergy (Fexofenadine Hydrochloride)
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Wal-Fex (Fexofenadine Hydrochloride)
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