Main Street Compounding Pharmacy Recalls Bacteriostatic Water Vials
Main Street Family Pharmacy is recalling Bacteriostatic Water 30ml vials due to seven reports of skin abscesses linked to compounded methylprednisolone.
The agency’s classification
FDA (Drugs): Class II
Class II is 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.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The recall is classified as FDA Class II and involves reported adverse reactions (skin abscesses), meeting the criteria for a Severe rating.
Plain-English summary
Main Street Family Pharmacy, LLC is recalling Bacteriostatic Water 30ml vials. The recall involves 2,462 units distributed nationwide to 38 states and the District of Columbia. The affected units are those with codes distributed prior to and including May 23, 2013.
The recall was initiated after the firm received seven reports of adverse reactions in the form of skin abscesses. These reactions were potentially linked to compounded preservative-free methylprednisolone 80mg/ml 10 ml vials.
Consumers who have purchased these products should stop using them and contact the recalling firm for further instructions.
The recalled product
- Product
- Bacteriostatic Water 30ml, Main Street Compounding Pharmacy, 126 East Main Street, Newbern, TN 38059, 888-658-6200
- Manufacturer
- Main Street Family Pharmacy, LLC
- Category
- Drug — Compounded Injectable
- Hazard
- Affected units
- 2,462
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- all codes distributed prior to and including 05/23/2013
Distribution
Part of a larger recall action
This product is one of 299 recalled by Main Street Family Pharmacy, LLC under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 299 products in this recall →Related recalls
Same manufacturer · Main Street Family Pharmacy, LLC
See all →- SevereMain Street Compounding Pharmacy Recalls Acetylcystein 10% Vials
FDA (Drugs) · 2013-12-11
- SevereMain Street Compounding Pharmacy Recalls Minoxidil 10% Due to Adverse Reactions
FDA (Drugs) · 2013-12-11
- SevereMain Street Compounding Pharmacy Recalls HCG 11000u w/B-12
FDA (Drugs) · 2013-12-11
- SevereMain Street Compounding Pharmacy Recalls Brompheniramine Due to Adverse Reactions
FDA (Drugs) · 2013-12-11
- SevereMain Street Compounding Pharmacy Recalls Methylcobalamin Due to Adverse Reaction Reports
FDA (Drugs) · 2013-12-11
Same hazard · infection
See all →- SevereMedtronic Recalls Grafton DBM Products Due to Donor Microbial Presence
FDA (Devices) · 2026-10-21
- SevereMedtronic Recalls Grafton DBM Allografts Due to Donor Microbial Presence
FDA (Devices) · 2026-10-21
- SevereStryker Bard EP XT Decapolar Steerable Diagnostic EP Catheter Recalled for Sterile Barrier Breach
FDA (Devices) · 2026-10-14
- SevereSafeguard US Operating LLC Recalls Compression Bandages Due to Degradation
FDA (Devices) · 2026-10-14
- HighFDA Recalls Performance Pro Nitrile Gloves Due to Defects
FDA (Devices) · 2026-10-07
Similar recalls
- SevereUS Compounding Recalls Methylprednisolone Vials Due to Sterility Concerns
FDA (Drugs) · 2015-11-25
- CriticalFDA Recalls Methylprednisolone Acetate Injection Due to Non-Sterility
FDA (Drugs) · 2013-01-09
- SevereAnderson Compounding Pharmacy Recalls Prostaglandin Tri-Mix Vials for Sterility Concerns
FDA (Drugs) · 2019-04-24
- SevereGreen Valley Drugs Recalls Bacteriostatic Water for Injection Due to Sterility Concerns
FDA (Drugs) · 2013-05-22
- SevereUS Compounding Recalls Methylprednisolone/Lidocaine Vials Due to Sterility Concerns
FDA (Drugs) · 2015-11-25
- SevereFDA Recalls Prostaglandin Tri-Mix Vials Due to Sterility Concerns
FDA (Drugs) · 2019-04-24