Recall Register

Drug recall: Acetylcysteine 10% Ophthalmic Eye Drop 2 mL droptainer, Anderson Compounding Pharmacy 310 Bluff City Hwy Bristol, TN.

Class II FDA enforcement event 82554. Recall start date: . Status in the FDA record: Terminated. Termination date: .

Reason for recall, in the words of FDA

Lack of sterility assurance.

Class II, in the words of FDA

a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote

Anderson Compounding Pharmacy, Inc. DBA Anderson Compounding Pharmacy started this drug recall on 2 Apr 2019. The firm address in the FDA record is in Bristol, TN. FDA put the recall in Class II. FDA event 82554 has 68 product records. The first FDA enforcement report date is 24 Apr 2019. The record gives the status Terminated, with the termination date 24 Sep 2021.

It is important to note that most of the time recall classifications are determined after the recalling firm provides all of the information needed to determine the risk posed to public health. The classification and posting in the FDA Enforcement Report should not be seen as an expansion or change to a firm’s voluntary public warning.

FDA publishes these words. Source: FDA, Enforcement Reports, Important Note, read on . openFDA export of .

Distribution

In the words of FDA.

Nationwide

Recalling firm

Anderson Compounding Pharmacy, Inc. DBA Anderson Compounding Pharmacy, Bristol, TN.

Recalling firm: The firm that the FDA record names for a recall.

FDA records how the recall started: Voluntary: Firm initiated.

Products

68 product records in the event.

FDA event 82554: product records
Recall numberProductQuantityClassStatusReport date
D-1137-2019Acetylcysteine 10% Ophthalmic Eye Drop 2 mL droptainer, Anderson Compounding Pharmacy 310 Bluff City Hwy Bristol, TN.10 drop containersClass IITerminated24 Apr 2019
D-1138-2019Atropine 0.01% Eye Drops, 1 mL and 2 mL Dropper, Anderson Compounding Pharmacy 310 Bluff City Hwy, Bristol, TN.UnknownClass IITerminated24 Apr 2019
D-1139-2019Amphotericin B 0.15% Eye Drops, 2 mL Droppers, Anderson Compounding Pharmacy 310 Bluff City Hwy Bristol, TN.5 drop containersClass IITerminated24 Apr 2019
D-1140-2019Vancomycin 125 mg/3mL Inhalation, 3 mL Vial, Anderson Compounding Pharmacy 310 Bluff City Hwy, Bristol, TN.N/AClass IITerminated24 Apr 2019
D-1141-2019Dexamethasone 24 mg/mL Injection, 10 mL Vial, Anderson Compounding Pharmacy, 310 Bluff City Hwy, Bristol, TN.3 vialsClass IITerminated24 Apr 2019
D-1142-2019DMSO 50% 60 mL/Heparin 1 mL/ Sodium Bicarbonate 60 mL/ Solu-Cortef 100 mg, 41 mL syringe, Anderson Compounding Pharmacy 310 Bluff City Hwy, Bristol, TN.1 syringeClass IITerminated24 Apr 2019
D-1143-2019Estradiol Cypionate 10 mg/mL, 5 mL Vial, Anderson Compounding Pharmacy 310 Bluff City Hwy, Bristol, TN.35 vialsClass IITerminated24 Apr 2019
D-1144-2019Gentamicin 120 mg/250 mL 0.9% Sodium Chloride for Irrigation, 30 mL Syringe, Anderson Compounding Pharmacy 310 Bluff City Hwy, Bristol, TN.6 syringesClass IITerminated24 Apr 2019
D-1145-2019Gentamicin 250 mg/1000 mL Irrigation, 1000 mL, Anderson Compounding Pharmacy 310 Bluff City Hwy, Bristol, TN.4 bottlesClass IITerminated24 Apr 2019
D-1146-2019HCG 1,000 U/mL Injection, 30 mL, Vial Anderson Compounding Pharmacy 310 Bluff City Hwy, Bristol, TN.1 vialClass IITerminated24 Apr 2019
D-1147-2019HCG 11,000 Units, 30 mL Vial, Anderson Compounding Pharmacy 310 Bluff City Hwy, Bristol, TN.9 vialsClass IITerminated24 Apr 2019
D-1148-2019HCG 20 Day Injection, 2625 Units/4 mL, Anderson Compounding Pharmacy 310 Bluff City Hwy, Bristol, TN.217 vialsClass IITerminated24 Apr 2019
D-1149-2019HCG 23 Day, 2876 Units/4.6 mL Vial, Anderson Compounding Pharmacy 310 Bluff City Hwy, Bristol, TN.31 vialsClass IITerminated24 Apr 2019
D-1150-2019HCG 30 Day, 3750 Units/6 mL, 10 mL Vial, Anderson Compounding Pharmacy 310 Bluff City Hwy, Bristol, TN 1-800-263-889057 vialsClass IITerminated24 Apr 2019
D-1151-2019HCG 20 Day Extra Strength, 3500 Units/4 mL, 10 mL Vial, Anderson Compounding Pharmacy 310 Bluff City Hwy, Bristol, TN.99 vialsClass IITerminated24 Apr 2019
D-1152-2019HCG 20,000 units/vial, Anderson Compounding Pharmacy 310 Bluff City Hwy, Bristol, TN.1 vialClass IITerminated24 Apr 2019
D-1153-2019HCG 23 Day Injection Extra Strength, vials, Anderson Compounding Pharmacy 310 Bluff City Hwy, Bristol, TN 1-800-263-889014 vialsClass IITerminated24 Apr 2019
D-1154-2019HCG 4,100 Units/vial Injection, Anderson Compounding Pharmacy 310 Bluff City Hwy, Bristol, TN.1 vialClass IITerminated24 Apr 2019
D-1155-2019HCG 40 Day Injection Extra Strength, vials, Anderson Compounding Pharmacy 310 Bluff City Hwy, Bristol, TN.2 vialsClass IITerminated24 Apr 2019
D-1156-2019Heparin 20,000 U/Lidocaine 2% 10 mL/Sodium Bicarbonate 8.4% 10 mL/Sterile Water 5 mL, 27 mL Syringe, Anderson Compounding Pharmacy 310 Bluff City Hwy, Bristol, TN.2 syringesClass IITerminated24 Apr 2019
D-1157-2019Heparin 10 mL/ Marcain 0.25% 20 mL/Sodium Bicarbonate 8.4%-40 mL/ Normal Saline 5 mL, 60 mL Syringe, Anderson Compounding Pharmacy 310 Bluff City Hwy, Bristol, TN.1 syringeClass IITerminated24 Apr 2019
D-1158-2019Heparin 10,000 U/Bupivacaine 0.5% 10 mL, Sodium Bicarbonate 8.4% 50 mL, 61 mL Syringe, Anderson Compounding Pharmacy 310 Bluff City Hwy, Bristol, TN.1 syringeClass IITerminated24 Apr 2019
D-1159-2019Heparin 10 mL/Marcain 0.25% 20 mL/Sodium Bicarbonate 8.4%-40 mL/per 70 mL, Anderson Compounding Pharmacy 310 Bluff City Hwy, Bristol, TN.12 syringesClass IITerminated24 Apr 2019
D-1160-2019Heparin 2 mL/Lidocaine 2%-10 mL/Sodium Bicarbonate 8.4%-5mL/ Sterile Water 10 mL, Anderson Compounding Pharmacy 310 Bluff City Hwy, Bristol, TN.6 syringesClass IITerminated24 Apr 2019
D-1161-2019Methionine 15mg/Choline 100mg/ Inositol 50mg/ Methylcobalamin 1mg/ Lidocoaine 10 mg, benzyl alcohol/ water, Anderson Compounding Pharmacy 310 Bluff City Hwy, Bristol, TN.276 vailsClass IITerminated24 Apr 2019
D-1162-2019Methylcobalamin 1 mg/mL Injection, 2 mL Vial, Anderson Compounding Pharmacy 310 Bluff City Hwy, Bristol, TN.5 vialsClass IITerminated24 Apr 2019
D-1163-2019Methylprednisolone 1% PF Ophthalmic, 3 mL Droppers, Anderson Compounding Pharmacy 310 Bluff City Hwy, Bristol, TN.5 drop containersClass IITerminated24 Apr 2019
D-1164-2019Morphine Sulfate 5 mg/3mL Inhalation, 3 mL Vials, Anderson Compounding Pharmacy 310 Bluff City Hwy, Bristol, TN.60 vialsClass IITerminated24 Apr 2019
D-1165-2019Penicillin G 100,000/mL 10 mL Syringe, Anderson Compounding Pharmacy 310 Bluff City Hwy, Bristol, TN.1 vialClass IITerminated24 Apr 2019
D-1166-2019Phenylephrine 1 mg/mL Injection, 10 mL Vial, Anderson Compounding Pharmacy 310 Bluff City Hwy, Bristol, TN.1 vialClass IITerminated24 Apr 2019
D-1167-2019Polyhexamethylene Biguanide 0.02% Ophthalmic Drops, 2 mL Dropper, Anderson Compounding Pharmacy 310 Bluff City Hwy, Bristol, TN.5 drop containersClass IITerminated24 Apr 2019
D-1168-2019Prostaglandin 20 mcg/mL, 10 mL Vial, Anderson Compounding Pharmacy 310 Bluff City Hwy, Bristol, TN.23 vialsClass IITerminated24 Apr 2019
D-1169-2019Prostaglandin 40 mcg/mL, Vial, Anderson Compounding Pharmacy 310 Bluff City Hwy, Bristol, TN.6 vialsClass IITerminated24 Apr 2019
D-1170-2019Prostaglandin 60 mcg/mL, Vial, Anderson Compounding Pharmacy 310 Bluff City Hwy, Bristol, TN.5 vialsClass IITerminated24 Apr 2019
D-1171-2019Prostaglandin Quad-Mix 20:30:1:0.15 Injection, 10 mL Vial, Anderson Compounding Pharmacy 310 Bluff City Hwy, Bristol, TN.40 vialsClass IITerminated24 Apr 2019
D-1172-2019Prostaglandin Quad with Atropine 10:30:1:0.15, 2 mL Vial, Anderson Compounding Pharmacy 310 Bluff City Hwy, Bristol, TN.5 vialsClass IITerminated24 Apr 2019
D-1173-2019Prostaglandin Tri-Mix 20:30:1, 10 mL Vial, Anderson Compounding Pharmacy 310 Bluff City Hwy, Bristol, TN.58 vialsClass IITerminated24 Apr 2019
D-1174-2019Prostaglandin Tri-Mix 50:30:1, 10 mL Vial, Anderson Compounding Pharmacy 310 Bluff City Hwy, Bristol, TN.31 vialsClass IITerminated24 Apr 2019
D-1175-2019Sermorelin 0.3 mg/0.5 mL, 10 mL Vial, Anderson Compounding Pharmacy 310 Bluff City Hwy, Bristol, TN.22 vialsClass IITerminated24 Apr 2019
D-1176-2019Sermorelin 0.4 mg/0.5 mL, 10 mL Vial, Anderson Compounding Pharmacy 310 Bluff City Hwy, Bristol, TN.6 vialsClass IITerminated24 Apr 2019
D-1177-2019Serum Tears 20% Drops, 1 mL Droptainer, Anderson Compounding Pharmacy 310 Bluff City Hwy, Bristol, TN.40 drop containersClass IITerminated24 Apr 2019
D-1178-2019Serum Tears 30% Drops, 1 mL Droptainer, Anderson Compounding Pharmacy 310 Bluff City Hwy, Bristol, TN.60 drop containersClass IITerminated24 Apr 2019
D-1179-2019Streptomycin 24 mg/Dexamethasone 10 mg/mL Otic Injection, 1 mL Syringe, Anderson Compounding Pharmacy 310 Bluff City Hwy, Bristol, TN.10 syringesClass IITerminated24 Apr 2019
D-1180-2019Bacitracin 3000U/30 mL Irrigation, 30 mL Syringe, Anderson Compounding Pharmacy 310 Bluff City Hwy, Bristol, TN.2 vialsClass IITerminated24 Apr 2019
D-1181-2019Testosterone Cypionate 250 mg/mL Sterile Injection, 5 mL Vial, Anderson Compounding Pharmacy 310 Bluff City Hwy, Bristol, TN.5 vialsClass IITerminated24 Apr 2019
D-1182-2019Vitamin D3 200,000 IU/mL Injection, 2 mL Vial, Anderson Compounding Pharmacy 310 Bluff City Hwy, Bristol, TN.4 vialsClass IITerminated24 Apr 2019
D-1183-2019Methylcobalamin 3000 mcg/mL Injection Solution, 2 mL Vial, Anderson Compounding Pharmacy 310 Bluff City Hwy, Bristol, TN.N/AClass IITerminated24 Apr 2019
D-1184-2019Serum Tears 50% Ophthalmic Drops, 1 mL Dropper, Anderson Compounding Pharmacy 310 Bluff City Hwy, Bristol, TN.N/AClass IITerminated24 Apr 2019
D-1185-2019Interferon 1 Million IU/mL Eye Drops, 1 mL Droptainer, Anderson Compounding Pharmacy 310 Bluff City Hwy, Bristol, TN.N/AClass IITerminated24 Apr 2019
D-1186-2019Prostaglandin Tri-Mix 60:30:1 Injection, 2 mL Vial, Anderson Compounding Pharmacy 310 Bluff City Hwy, Bristol, TN.N/AClass IITerminated24 Apr 2019
D-1187-2019Neomycin 40 mg/Polymixin B 200,000 Bladder Irrigation Solution, 1000 mL bottle, Anderson Compounding Pharmacy 310 Bluff City Hwy, Bristol, TN.N/AClass IITerminated24 Apr 2019
D-1188-2019Lidocaine 1%/Dextrose 12.5% (PF) Injection, 10 mL Vial, Anderson Compounding Pharmacy 310 Bluff City Hwy, Bristol, TN.N/AClass IITerminated24 Apr 2019
D-1189-2019EDTA 1% Sterile Injection (Preservative Free), Anderson Compounding Pharmacy 310 Bluff City Hwy, Bristol, TN.N/AClass IITerminated24 Apr 2019
D-1190-2019Sodium Bicarbonate 8.4% Injection, 10 mL Vial, Anderson Compounding Pharmacy 310 Bluff City Hwy, Bristol, TN.N/AClass IITerminated24 Apr 2019
D-1191-2019Heparin 20,000U/Marcaine 0.25%, 10 mL, Sodium Bicarbonate 8.4% 48 mL, 60 mL Syringe, Anderson Compounding Pharmacy 310 Bluff City Hwy, Bristol, TN.N/AClass IITerminated24 Apr 2019
D-1192-2019Gentamicin 160 mg/1000 mL Sterile Water for Irrigation,1000 mL Bottle, Anderson Compounding Pharmacy 310 Bluff City Hwy, Bristol, TN.N/AClass IITerminated24 Apr 2019
D-1193-2019Gentamicin 240 mg/500 mL Sterile Water for Irrigation,60 mL Syringe, Anderson Compounding Pharmacy 310 Bluff City Hwy, Bristol, TN.N/AClass IITerminated24 Apr 2019
D-1194-2019Heparin 10 mL/Marcaine 0.25% 20 mL/Sodium Bicarbonate 40 mL/Normal Saline 5 mL per 75 mL, 60 mL Syringe, Anderson Compounding Pharmacy 310 Bluff City Hwy, Bristol, TN.N/AClass IITerminated24 Apr 2019
D-1195-2019Estrone 5mg/mL Oil Injection, 10 mL Vial, Anderson Compounding Pharmacy 310 Bluff City Hwy, Bristol, TN.N/AClass IITerminated24 Apr 2019
D-1196-2019HCG 11,00Units/B 12 11,000 mcg Injection, 30 mL Vial, Anderson Compounding Pharmacy 310 Bluff City Hwy, Bristol, TN.N/AClass IITerminated24 Apr 2019

The table shows 60 of 68 product records. The FDA enforcement report lists all the records.

openFDA, about the status: FDA does not update the status of a recall after the recall has been classified according to its level of hazard. As such, the status of a recall (open, completed, or terminated) will remain unchanged after published in the Enforcement Reports. Source: openFDA, Drug Recall Enforcement Reports, Disclaimer.

Enforcement report: The FDA publication that lists recalls. It has one record for each product of a recall.

Enforcement event: All the product records that have one FDA event number. This site shows one event on one page.

Class II: The middle of the three FDA recall classes.

The event in context

Drug events that started in 2019
362
Share of these events in Class II
68%
Product records in this event
68
Events of the firm on the register
1

Official channels

Cite this page

Recall Register. FDA enforcement event 82554. https://recallregister.com/fda/ii/82554/. Source: openFDA enforcement reports. Data through .

Sources

Source
openFDA drug enforcement reports
Licence
CC0 1.0
Export date
28 Sep 2026
Newest FDA report date on the register
23 Sep 2026

FDA has one record for each product. This site puts the records with the same event number on one page. The class of the event is the highest class of its records. How the register is made. Report an error.

Questions

Where was the product distributed?
The FDA record gives this distribution: Nationwide
What quantity of product is in FDA event 82554?
The event has 68 product records. The first record gives this quantity: 10 drop containers
How did the recall start?
The FDA record says: Voluntary: Firm initiated
How many drug recalls of 2019 have the same class?
68% of the 362 drug events that started in 2019 are in Class II.