CLASS II Drug recall · Reported 11 Dec 2013 · FDA Enforcement Report

Dexamethasone sodium phosphate recalled by Main Street Family Pharmacy

Main Street Family Pharmacy is recalling Dexamethasone sodium phosphate, Main Street Compounding Pharmacy, 126 East Main Street, distributed nationwide in the US. The recall was initiated on 28 May 2013 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesall codes distributed prior to and including 05/23/2013

Quantity recalled1 unit

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-079-2014
FDA event ID: 65479
Recalling firm: Main Street Family Pharmacy, Newbern, TN
Classification: Class II
Status: Terminated
Recall initiated: 28 May 2013
FDA classified: 3 Dec 2013
Reported: 11 Dec 2013
Type: Voluntary: Firm initiated
Customers notified by: Telephone
Reason category: Other Reasons
Drug class: Compounded Drugs

Timeline

28 May 2013	Recall initiated by company
3 Dec 2013	Classified by FDA	+189 days
11 Dec 2013	Published in enforcement report	+8 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

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.

Product as listed by the FDA

Dexamethasone sodium phosphate, Main Street Compounding Pharmacy, 126 East Main Street, Newbern, TN 38059, 888-658-6200

Where it was distributed

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

Nationwide Alaska Alabama Arizona California Colorado Connecticut District of Columbia Florida Georgia Hawaii Illinois Indiana Kansas Kentucky Louisiana Massachusetts Maryland Minnesota Missouri Mississippi

Questions about this recall

Is Dexamethasone sodium phosphate, Main Street Compounding Pharmacy, 126 East Main Street recalled?

Yes. Main Street Family Pharmacy recalled Dexamethasone sodium phosphate, Main Street Compounding Pharmacy, 126 East Main Street on 28 May 2013. The recall is Class II and its status is Terminated. Recall number D-079-2014.

Why was it recalled?

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.

Which lots are affected?

all codes distributed prior to and including 05/23/2013

Where was it sold?

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

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 Main Street Family Pharmacy

All 299

Reported	Class	Recall	Company	Reason	Where
11 Dec 2013Drug	CLASS II	Mitomycin 40mg, Main Street Compounding Pharmacy recalled	Main Street Family Pharmacy	Other	Nationwide
11 Dec 2013Drug	CLASS II	HCG 5000iu kit, Main Street Compounding Pharmacy recalled	Main Street Family Pharmacy	Other	Nationwide
11 Dec 2013Drug	CLASS II	HCG 5,000U, Main Street Compounding Pharmacy recalled	Main Street Family Pharmacy	Other	Nationwide
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11 Dec 2013Drug	CLASS II	HCG 3000IU, Main Street Compounding Pharmacy recalled	Main Street Family Pharmacy	Other	Nationwide