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Anderson Compounding Pharmacy, Inc.

FDA Regulatory Profile

Anderson Compounding Pharmacy, Inc. has 68 FDA recalls, 2 inspections, 0 510(k) clearances and 1 compliance action on record.

Latest recall
D-1141-2019 · Class II · Apr 2, 2019
Latest inspection
Sep 9, 2021 · NAI

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Summary

Record counts and when each FDA source was last refreshed
RecordsCountLast refreshedSource as ofStatus
Recalls68Nov 4, 2026 (checked Nov 8, 2026, unchanged)File dated Nov 3, 2026Current
510(k) clearances0Nov 8, 2026File dated Nov 2, 2026Current
Inspections2Nov 9, 2026Newest record Oct 28, 2026Current
Compliance actions1Nov 2, 2026Newest record Oct 29, 2026Current

Recent Recalls

NumberClassProductDate
D-1141-2019Class IIDexamethasone 24 mg/mL Injection, 10 mL Vial, Anderson Compounding Pharmacy, 310 Bluff City Hwy…Apr 2, 2019
D-1147-2019Class IIHCG 11,000 Units, 30 mL Vial, Anderson Compounding Pharmacy 310 Bluff City Hwy, Bristol, TN.Apr 2, 2019
D-1193-2019Class IIGentamicin 240 mg/500 mL Sterile Water for Irrigation,60 mL Syringe, Anderson Compounding Pharmacy…Apr 2, 2019
D-1152-2019Class IIHCG 20,000 units/vial, Anderson Compounding Pharmacy 310 Bluff City Hwy, Bristol, TN.Apr 2, 2019
D-1142-2019Class IIDMSO 50% 60 mL/Heparin 1 mL/ Sodium Bicarbonate 60 mL/ Solu-Cortef 100 mg, 41 mL syringe, Anderson…Apr 2, 2019
D-1175-2019Class IISermorelin 0.3 mg/0.5 mL, 10 mL Vial, Anderson Compounding Pharmacy 310 Bluff City Hwy, Bristol, TN.Apr 2, 2019
D-1176-2019Class IISermorelin 0.4 mg/0.5 mL, 10 mL Vial, Anderson Compounding Pharmacy 310 Bluff City Hwy, Bristol, TN.Apr 2, 2019
D-1161-2019Class IIMethionine 15mg/Choline 100mg/ Inositol 50mg/ Methylcobalamin 1mg/ Lidocoaine 10 mg, benzyl alcohol/…Apr 2, 2019
D-1162-2019Class IIMethylcobalamin 1 mg/mL Injection, 2 mL Vial, Anderson Compounding Pharmacy 310 Bluff City Hwy…Apr 2, 2019
D-1170-2019Class IIProstaglandin 60 mcg/mL, Vial, Anderson Compounding Pharmacy 310 Bluff City Hwy, Bristol, TN.Apr 2, 2019
D-1171-2019Class IIProstaglandin Quad-Mix 20:30:1:0.15 Injection, 10 mL Vial, Anderson Compounding Pharmacy 310 Bluff…Apr 2, 2019
D-1182-2019Class IIVitamin D3 200,000 IU/mL Injection, 2 mL Vial, Anderson Compounding Pharmacy 310 Bluff City Hwy…Apr 2, 2019
D-1180-2019Class IIBacitracin 3000U/30 mL Irrigation, 30 mL Syringe, Anderson Compounding Pharmacy 310 Bluff City Hwy…Apr 2, 2019
D-1145-2019Class IIGentamicin 250 mg/1000 mL Irrigation, 1000 mL, Anderson Compounding Pharmacy 310 Bluff City Hwy…Apr 2, 2019
D-1143-2019Class IIEstradiol Cypionate 10 mg/mL, 5 mL Vial, Anderson Compounding Pharmacy 310 Bluff City Hwy, Bristol…Apr 2, 2019
D-1166-2019Class IIPhenylephrine 1 mg/mL Injection, 10 mL Vial, Anderson Compounding Pharmacy 310 Bluff City Hwy…Apr 2, 2019
D-1151-2019Class IIHCG 20 Day Extra Strength, 3500 Units/4 mL, 10 mL Vial, Anderson Compounding Pharmacy 310 Bluff City…Apr 2, 2019
D-1174-2019Class IIProstaglandin Tri-Mix 50:30:1, 10 mL Vial, Anderson Compounding Pharmacy 310 Bluff City Hwy…Apr 2, 2019
D-1149-2019Class IIHCG 23 Day, 2876 Units/4.6 mL Vial, Anderson Compounding Pharmacy 310 Bluff City Hwy, Bristol, TN.Apr 2, 2019
D-1167-2019Class IIPolyhexamethylene Biguanide 0.02% Ophthalmic Drops, 2 mL Dropper, Anderson Compounding Pharmacy 310…Apr 2, 2019

Recent FDA Inspections

DateSiteProductClassificationFEI
Sep 9, 2021Bristol, TNDrugsNo Action Indicated (NAI)3014877770
Apr 5, 2019Bristol, TNDrugsOfficial Action Indicated (OAI)3014877770

NAI means no objectionable conditions or practices were found during the inspection. VAI means objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action. OAI means regulatory and/or administrative actions are recommended.

FDA-Inspected Facilities

FacilityLocationInspectionsLatest
FEI 3014877770Bristol, TN2Sep 9, 2021

FDA data resources

Sources: openFDA, FDA Data Dashboard, FDA.gov. Report a data issue: hello@regdatalab.com.