CLASS II Drug recall · Reported 24 Apr 2019 · FDA Enforcement Report
Gentamicin 250 mg/ Irrigation recalled by Anderson Compounding Pharmacy
Anderson Compounding Pharmacy is recalling Gentamicin 250 mg/ Irrigation, Anderson Compounding Pharmacy 310 Bluff City Hwy, Bristol, distributed nationwide in the US. The recall was initiated on 2 Apr 2019 and the FDA has classified it as Class II.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-1145-2019
- FDA event ID
- 82554
- Recalling firm
- Anderson Compounding Pharmacy, Bristol, TN
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 2 Apr 2019
- FDA classified
- 18 Apr 2019
- Reported
- 24 Apr 2019
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Sterility
- Drug class
- Compounded Drugs
Timeline
| 2 Apr 2019 | Recall initiated by company | |
| 18 Apr 2019 | Classified by FDA | +16 days |
| 24 Apr 2019 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Lack of sterility assurance.
A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.
Product as listed by the FDA
Gentamicin 250 mg/1000 mL Irrigation, 1000 mL, Anderson Compounding Pharmacy 310 Bluff City Hwy, Bristol, TN.
Where it was distributed
Nationwide
Questions about this recall
Is Gentamicin 250 mg/ Irrigation, Anderson Compounding Pharmacy 310 Bluff City Hwy, Bristol recalled?
Yes. Anderson Compounding Pharmacy recalled Gentamicin 250 mg/ Irrigation, Anderson Compounding Pharmacy 310 Bluff City Hwy, Bristol on 2 Apr 2019. The recall is Class II and its status is Terminated. Recall number D-1145-2019.
Why was it recalled?
Lack of sterility assurance.
Which lots are affected?
All Lots
Where was it sold?
Nationwide
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Anderson Compounding Pharmacy
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|---|---|---|---|---|---|
| Drug | CLASS II | Prostaglandin 20 mcg/mL Vial recalled by Anderson Compounding Pharmacy | Anderson Compounding Pharmacy | Sterility | Nationwide |
| Drug | CLASS II | Prostaglandin Tri-Mix 50:30:1 Vial recalled | Anderson Compounding Pharmacy | Sterility | Nationwide |
| Drug | CLASS II | Phenol 10% Injection Vial, Anderson Compounding Pharmacy recalled | Anderson Compounding Pharmacy | Sterility | Nationwide |
| Drug | CLASS II | Prostaglandin Quad-Mix 20:30:1 15 Injection Vial recalled | Anderson Compounding Pharmacy | Sterility | Nationwide |
| Drug | CLASS II | HCG 20 Day Extra Strength Vial recalled by Anderson Compounding Pharmacy | Anderson Compounding Pharmacy | Sterility | Nationwide |