Class II · Moderate risk
Atropine Sulfate injection
Presence of Particulate Matter: Product contaminated with particulate matter identified as hair, glass and/or paraformaldehyde
Atropine 0.01% Eye Drops
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Why it was recalled
Lack of sterility assurance.
Cause type: Sterility / contamination
A product that must be sterile could not be assured sterile, or was contaminated. A top reason for injectables, eye drops and IV products - loss of sterility assurance can lead to serious infections. All sterility / contamination recalls.
What was recalled
Atropine 0.01% Eye Drops, 1 mL and 2 mL Dropper, Anderson Compounding Pharmacy 310 Bluff City Hwy, Bristol, TN.
Drug: Atropine Category: Eye Drops & Ophthalmic
- Recalling firm
- Anderson Compounding Pharmacy, Inc. DBA Anderson Compounding Pharmacy
- Origin
- TN, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-1138-2019 · 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 Atropine recalls
See all
Class III · Low risk
Atropine Sulfate Ophthalmic Solution
Failed Impurities/Degradation Specifications
Class I · High risk
Atropine Sulfate Injection
Presence of Particulate Matter; identified as glass
Class II · Moderate risk
Atropine Sulfate Injection
Presence of Particulate Matter: Particulate matter identified as fiber.
Class II · Moderate risk
Atropine Sulfate Ophthalmic Solution
CGMP Deviations: Firm went out of business and could no longer continue stability studies.
Other recalls by Anderson Compounding Pharmacy, Inc. DBA Anderson Compounding Pharmacy
All 2019 recalls
Class II · Moderate risk
Prostaglandin Tri-Mix 30:30:1 Injection
Lack of sterility assurance.
Class II · Moderate risk
Prostaglandin Tri-Mix 20:25:1 Injection
Lack of sterility assurance.
Class II · Moderate risk
Prostaglandin Tri-Mix 8.33:22.5:0.833 Injection
Lack of sterility assurance.
Class II · Moderate risk
Prostaglandin Tri-Mix 2.5:7.5:0.25 Injection
Lack of sterility assurance.
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