Drug recall: 17-P 1ml, Main Street Compounding Pharmacy, 126 East Main Street, Newbern, TN 38059, 888-658-6200

FDA enforcement event 65479 · Class I · initiated 28 May 2013 · status Terminated · terminated 22 Apr 2014

DrugVoluntary: Firm initiated299 product recordsNewbern, TN

an individual recalling firm (name withheld) (Newbern, TN) initiated this drug recall on 28 May 2013; FDA lists 299 product records under event 65479, classified Class I.

FDA defines Class I as a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death. 18% of the 370 drug enforcement events initiated in 2013 carry the same class.

Status: Terminated, terminated 22 Apr 2014. Initiation: voluntary: firm initiated.

Recall classification reflects the relative degree of health hazard. Text in quotation marks is FDA's. openFDA export dated 28 Sep 2026.

Recalling firm

Individual recalling firm (name withheld), Newbern, TN. FDA names an individual as the recalling firm; this site does not publish people's names.

Reason for recall

"The firm received seven reports of adverse reactions in the form of skin abscesses potentially linked to compounded preservative-free methylprednisolone 80mg/ml 10 ml vials."

Distribution

"nationwide, specifically: AK, AL, AZ, CA, CO, CT, DC, FL, GA, HI, IL, IN, KS, KY, LA, MA, MD, MN, MO, MS, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, WI, and WV"

Product records

Recall number	Product	Quantity	Class	Status	Report date
D-024-2014	17-P 1ml, Main Street Compounding Pharmacy, 126 East Main Street, Newbern, TN 38059, 888-658-6200	875 units	Class II	Terminated	11 Dec 2013
D-025-2014	Acetylcystein 10% 120ml, Main Street Compounding Pharmacy, 126 East Main Street, Newbern, TN 38059, 888-658-6200	1 unit	Class II	Terminated	11 Dec 2013
D-026-2014	Acetylcystein 10% 100mg/ml 4ml, Main Street Compounding Pharmacy, 126 East Main Street, Newbern, TN 38059, 888-658-6200	1 unit	Class II	Terminated	11 Dec 2013
D-027-2014	Acetylcystein 20% 90ml, Main Street Compounding Pharmacy, 126 East Main Street, Newbern, TN 38059, 888-658-6200	1 unit	Class II	Terminated	11 Dec 2013
D-028-2014	Adenosine 35 mg/ml, 30ml, Main Street Compounding Pharmacy, 126 East Main Street, Newbern, TN 38059, 888-658-6200	39 units	Class II	Terminated	11 Dec 2013
D-029-2014	Adenosine Monophosphate, 50mg/ml 30ml, Main Street Compounding Pharmacy, 126 East Main Street, Newbern, TN 38059, 888-658-6200	15 units	Class II	Terminated	11 Dec 2013
D-030-2014	Alphahydroxyprogesterone, 250mg, Main Street Compounding Pharmacy, 126 East Main Street, Newbern, TN 38059, 888-658-6200	17 units	Class II	Terminated	11 Dec 2013
D-031-2014	Alprostadil 100mcg/ml 10ml, Main Street Compounding Pharmacy, 126 East Main Street, Newbern, TN 38059, 888-658-6200	8 units	Class II	Terminated	11 Dec 2013
D-032-2014	Alprostadil 20mcg/ml 25ml, Main Street Compounding Pharmacy, 126 East Main Street, Newbern, TN 38059, 888-658-6200	4 units	Class II	Terminated	11 Dec 2013
D-033-2014	Alprostadil 40mg, Main Street Compounding Pharmacy, 126 East Main Street, Newbern, TN 38059, 888-658-6200	1 unit	Class II	Terminated	11 Dec 2013
D-034-2014	AMIC-12 with lido 10ml, Main Street Compounding Pharmacy, 126 East Main Street, Newbern, TN 38059, 888-658-6200	7 units	Class II	Terminated	11 Dec 2013
D-035-2014	AMIC-12 w/out lido10ml , Main Street Compounding Pharmacy, 126 East Main Street, Newbern, TN 38059, 888-658-6200	1722 units	Class II	Terminated	11 Dec 2013
D-036-2014	Amikacin 250mg/ml 2ml, Main Street Compounding Pharmacy, 126 East Main Street, Newbern, TN 38059, 888-658-6200	50 units	Class II	Terminated	11 Dec 2013
D-037-2014	Amikacin 250mg/ml 2ml vial, Main Street Compounding Pharmacy, 126 East Main Street, Newbern, TN 38059, 888-658-6200	113 units	Class II	Terminated	11 Dec 2013
D-038-2014	Amikacin 500mg 2ml, Main Street Compounding Pharmacy, 126 East Main Street, Newbern, TN 38059, 888-658-6200	744 units	Class II	Terminated	11 Dec 2013
D-039-2014	Aminophylline 250mg 10ml, Main Street Compounding Pharmacy, 126 East Main Street, Newbern, TN 38059, 888-658-6200	6 units	Class II	Terminated	11 Dec 2013
D-040-2014	Aminophylline 25mg/ml 10ml, Main Street Compounding Pharmacy, 126 East Main Street, Newbern, TN 38059, 888-658-6200	25 units	Class II	Terminated	11 Dec 2013
D-041-2014	Ascorbic Acid 500mg/ml 50ml, Main Street Compounding Pharmacy, 126 East Main Street, Newbern, TN 38059, 888-658-6200	894 units	Class II	Terminated	11 Dec 2013
D-042-2014	B-12 (compounded) 30ml, Main Street Compounding Pharmacy, 126 East Main Street, Newbern, TN 38059, 888-658-6200	2157 units	Class II	Terminated	11 Dec 2013
D-043-2014	B-12 (Methyl) 30ml, Main Street Compounding Pharmacy, 126 East Main Street, Newbern, TN 38059, 888-658-6200	7 units	Class II	Terminated	11 Dec 2013
D-044-2014	B-12 0.5ml prefilled syringe, Main Street Compounding Pharmacy, 126 East Main Street, Newbern, TN 38059, 888-658-6200	116 units	Class II	Terminated	11 Dec 2013
D-045-2014	B-12 1ml prefilled syringe, Main Street Compounding Pharmacy, 126 East Main Street, Newbern, TN 38059, 888-658-6200	15 units	Class II	Terminated	11 Dec 2013
D-046-2014	B-12 mixture, Main Street Compounding Pharmacy, 126 East Main Street, Newbern, TN 38059, 888-658-6200	196 units	Class II	Terminated	11 Dec 2013
D-047-2014	B-12 PFS, Main Street Compounding Pharmacy, 126 East Main Street, Newbern, TN 38059, 888-658-6200	10 units	Class II	Terminated	11 Dec 2013
D-048-2014	B-12/Adenosine 10ml, Main Street Compounding Pharmacy, 126 East Main Street, Newbern, TN 38059, 888-658-6200	4 units	Class II	Terminated	11 Dec 2013
D-049-2014	Bacteriostatic Water 30ml, Main Street Compounding Pharmacy, 126 East Main Street, Newbern, TN 38059, 888-658-6200	2462 units	Class II	Terminated	11 Dec 2013
D-050-2014	B-Complex 100 30ml (PF), Main Street Compounding Pharmacy, 126 East Main Street, Newbern, TN 38059, 888-658-6200	35 units	Class II	Terminated	11 Dec 2013
D-051-2014	B-Complex 206 mg/ml 30ml, Main Street Compounding Pharmacy, 126 East Main Street, Newbern, TN 38059, 888-658-6200	1 unit	Class II	Terminated	11 Dec 2013
D-052-2014	Betamethasone Na phosphate 4mg/ml 10ml, Main Street Compounding Pharmacy, 126 East Main Street, Newbern, TN 38059, 888-658-6200	20 units	Class II	Terminated	11 Dec 2013
D-053-2014	Betamethasone 6.5mg 10ml, Main Street Compounding Pharmacy, 126 East Main Street, Newbern, TN 38059, 888-658-6200	9 units	Class II	Terminated	11 Dec 2013
D-054-2014	Betamethasone NA Phosphate (PF) 6mg/ml 10ml, Main Street Compounding Pharmacy, 126 East Main Street, Newbern, TN 38059, 888-658-6200	2 units	Class II	Terminated	11 Dec 2013
D-055-2014	Betamethasone 6mg 10ml, Main Street Compounding Pharmacy, 126 East Main Street, Newbern, TN 38059, 888-658-6200	6085 units	Class II	Terminated	11 Dec 2013
D-056-2014	Betamethasone 6mg 10ml PF, Main Street Compounding Pharmacy, 126 East Main Street, Newbern, TN 38059, 888-658-6200	2 units	Class II	Terminated	11 Dec 2013
D-057-2014	Betamethasone 6mg 30ml, Main Street Compounding Pharmacy, 126 East Main Street, Newbern, TN 38059, 888-658-6200	383 units	Class II	Terminated	11 Dec 2013
D-058-2014	Betamethasone 6mg PF 10ml, Main Street Compounding Pharmacy, 126 East Main Street, Newbern, TN 38059, 888-658-6200	2 units	Class II	Terminated	11 Dec 2013
D-059-2014	Betamethasone 7mg, Main Street Compounding Pharmacy, 126 East Main Street, Newbern, TN 38059, 888-658-6200	932 units	Class II	Terminated	11 Dec 2013
D-060-2014	Betamethasone 9mg, Main Street Compounding Pharmacy, 126 East Main Street, Newbern, TN 38059, 888-658-6200	12 units	Class II	Terminated	11 Dec 2013
D-061-2014	Betamethasone 9mg/ml PF, Main Street Compounding Pharmacy, 126 East Main Street, Newbern, TN 38059, 888-658-6200	43 units	Class II	Terminated	11 Dec 2013
D-062-2014	Betamethasone 10mg 10ml, Main Street Compounding Pharmacy, 126 East Main Street, Newbern, TN 38059, 888-658-6200	10 units	Class II	Terminated	11 Dec 2013
D-063-2014	Bi-Mix Papaverine 30 mg Phentolamine 1mg 10ml, Main Street Compounding Pharmacy, 126 East Main Street, Newbern, TN 38059, 888-658-6200	3 units	Class II	Terminated	11 Dec 2013
D-064-2014	Brompheniramine 10ml, Main Street Compounding Pharmacy, 126 East Main Street, Newbern, TN 38059, 888-658-6200	415 units	Class II	Terminated	11 Dec 2013
D-065-2014	Calcium Gluconate 10% 50ml, Main Street Compounding Pharmacy, 126 East Main Street, Newbern, TN 38059, 888-658-6200	25 units	Class II	Terminated	11 Dec 2013
D-066-2014	Calcium Gluconate 2.5% Gel, Main Street Compounding Pharmacy, 126 East Main Street, Newbern, TN 38059, 888-658-6200	5 units	Class II	Terminated	11 Dec 2013
D-067-2014	Carnitine 250mg/ml, Main Street Compounding Pharmacy, 126 East Main Street, Newbern, TN 38059, 888-658-6200	30 units	Class II	Terminated	11 Dec 2013
D-068-2014	Carnitine 250mg/ml, Main Street Compounding Pharmacy, 126 East Main Street, Newbern, TN 38059, 888-658-6200	30 units	Class II	Terminated	11 Dec 2013
D-069-2014	Cyclosporine Drops (compounded), Main Street Compounding Pharmacy, 126 East Main Street, Newbern, TN 38059, 888-658-6200	15 units	Class II	Terminated	11 Dec 2013
D-070-2014	Depo-Testadiiol, Main Street Compounding Pharmacy, 126 East Main Street, Newbern, TN 38059, 888-658-6200	2 units	Class II	Terminated	11 Dec 2013
D-071-2014	Dexamethasone LA 16mg/ml 10ml, Main Street Compounding Pharmacy, 126 East Main Street, Newbern, TN 38059, 888-658-6200	14 units	Class II	Terminated	11 Dec 2013
D-072-2014	Dexamethasone LA 16mg/ml 30ml, Main Street Compounding Pharmacy, 126 East Main Street, Newbern, TN 38059, 888-658-6200	54 units	Class II	Terminated	11 Dec 2013
D-073-2014	Dexamethasone 4/8, Main Street Compounding Pharmacy, 126 East Main Street, Newbern, TN 38059, 888-658-6200	311 units	Class II	Terminated	11 Dec 2013
D-074-2014	Dexamethasone 8/4 10ml and 30 ml, Main Street Compounding Pharmacy, 126 East Main Street, Newbern, TN 38059, 888-658-6200	115 units	Class II	Terminated	11 Dec 2013
D-075-2014	Dexamethasone 8mg 10ml, Main Street Compounding Pharmacy, 126 East Main Street, Newbern, TN 38059, 888-658-6200	17 units	Class II	Terminated	11 Dec 2013
D-076-2014	Dexamethasone LA 16mg, Main Street Compounding Pharmacy, 126 East Main Street, Newbern, TN 38059, 888-658-6200	151 units	Class II	Terminated	11 Dec 2013
D-077-2014	Dexamethasone LA 8mg/ml 10ml, Main Street Compounding Pharmacy, 126 East Main Street, Newbern, TN 38059, 888-658-6200	492 units	Class II	Terminated	11 Dec 2013
D-078-2014	Dexamethasone LA 16mg 30ml, Main Street Compounding Pharmacy, 126 East Main Street, Newbern, TN 38059, 888-658-6200	6 units	Class II	Terminated	11 Dec 2013
D-079-2014	Dexamethasone sodium phosphate, Main Street Compounding Pharmacy, 126 East Main Street, Newbern, TN 38059, 888-658-6200	1 unit	Class II	Terminated	11 Dec 2013
D-080-2014	Double Strength PGE1 40mcg 2ml, Main Street Compounding Pharmacy, 126 East Main Street, Newbern, TN 38059, 888-658-6200	1 unit	Class II	Terminated	11 Dec 2013
D-081-2014	Double Strength PGE1 40mcg/ml, Main Street Compounding Pharmacy, 126 East Main Street, Newbern, TN 38059, 888-658-6200	3 units	Class II	Terminated	11 Dec 2013
D-082-2014	Double Therapy Inj. SS ML, Main Street Compounding Pharmacy, 126 East Main Street, Newbern, TN 38059, 888-658-6200	10 units	Class II	Terminated	11 Dec 2013
D-083-2014	EDTA 150mg/ml 100ml, Main Street Compounding Pharmacy, 126 East Main Street, Newbern, TN 38059, 888-658-6200	25 units	Class II	Terminated	11 Dec 2013

Showing 60 of 299 product records; the FDA enforcement report lists all of them.

Context

18%of 2013 drug events are Class I370 events that year

299product records in this event

1event on this register for the firm

Questions and answers

Why was this drug recalled?

FDA's record gives the reason for recall as: "The firm received seven reports of adverse reactions in the form of skin abscesses potentially linked to compounded preservative-free methylprednisolone 80mg/ml 10 ml vials."

What does Class I mean?

FDA classifies recalls by relative degree of health hazard. Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.

Where was the product distributed?

FDA's distribution pattern field reads: "nationwide, specifically: AK, AL, AZ, CA, CO, CT, DC, FL, GA, HI, IL, IN, KS, KY, LA, MA, MD, MN, MO, MS, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, WI, and WV"

Is the recall still ongoing?

FDA lists the status as Terminated; the termination date is 22 Apr 2014. "Terminated" means FDA has determined that all reasonable efforts to remove or correct the product have been made.

Where does this data come from?

openFDA enforcement reports (food, drug and device), CC0, export dated 28 Sep 2026. Text in quotation marks is FDA's. The FDA enforcement report linked above is authoritative.

Provenance

Source: openFDA drug enforcement reports (CC0), export dated 28 Sep 2026; records grouped by FDA event number. The class shown for the event is the most severe class among its records. Errors in processing are corrected at the next build; see corrections.