Drug Recall Enforcement Reports

What are the Drug Enforcement Reports?

All drug recalls are monitored by the Food and Drug Administration (FDA) and are included in the Enforcement Report once they are properly classified. The FDA will determine if a firm's removal or correction actions of a marked product meet the requirements to be considered a "recall". The FDA will also determine the public hazard assessment and a recall classification will be published in the Enforcement Report.

The Drug Enforcement Reports included in this listing was last updated on October 09, 2026 and include a total of 18002 recall reports.

Recall Number	Recall Initiation Date	Product Description	Recall Reason	Recall Firm / Quantity	Recall Classification	Status
D-186-2014	05-28-2013	Lipotropic 30ml, Main Street Compounding Pharmacy, 126 East Main Street, Newbern, TN 38059, 888-658-6200	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.	Main Street Family Pharmacy, LLC / 8 units	Class II	Terminated
D-204-2014	05-28-2013	Mesotherapy, Main Street Compounding Pharmacy, 126 East Main Street, Newbern, TN 38059, 888-658-6200	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.	Main Street Family Pharmacy, LLC / 2 units	Class II	Terminated
D-194-2014	05-28-2013	Marcaine .1%/NS 400ml-pump, Main Street Compounding Pharmacy, 126 East Main Street, Newbern, TN 38059, 888-658-6200	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.	Main Street Family Pharmacy, LLC / 2 units	Class II	Terminated
D-083-2014	05-28-2013	EDTA 150mg/ml 100ml, Main Street Compounding Pharmacy, 126 East Main Street, Newbern, TN 38059, 888-658-6200	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.	Main Street Family Pharmacy, LLC / 25 units	Class II	Terminated
D-105-2014	05-28-2013	HCG 1000iu PFS, Main Street Compounding Pharmacy, 126 East Main Street, Newbern, TN 38059, 888-658-6200	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.	Main Street Family Pharmacy, LLC / 115 units	Class II	Terminated
D-239-2014	05-28-2013	Mic Ultra 50ml- Sulfur Free w/Lido, Main Street Compounding Pharmacy, 126 East Main Street, Newbern, TN 38059, 888-658-6200	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.	Main Street Family Pharmacy, LLC / 18 units	Class II	Terminated
D-130-2014	05-28-2013	HCG 290 iu prefilled syringes, Main Street Compounding Pharmacy, 126 East Main Street, Newbern, TN 38059, 888-658-6200	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.	Main Street Family Pharmacy, LLC / 4750 units	Class II	Terminated
D-248-2014	05-28-2013	Mitomycin 40mg, Main Street Compounding Pharmacy, 126 East Main Street, Newbern, TN 38059, 888-658-6200	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.	Main Street Family Pharmacy, LLC / 370 units	Class II	Terminated
D-049-2014	05-28-2013	Bacteriostatic Water 30ml, Main Street Compounding Pharmacy, 126 East Main Street, Newbern, TN 38059, 888-658-6200	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.	Main Street Family Pharmacy, LLC / 2462 units	Class II	Terminated
D-057-2014	05-28-2013	Betamethasone 6mg 30ml, Main Street Compounding Pharmacy, 126 East Main Street, Newbern, TN 38059, 888-658-6200	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.	Main Street Family Pharmacy, LLC / 383 units	Class II	Terminated
D-103-2014	05-28-2013	HCG 100 iu prefilled syringes, Main Street Compounding Pharmacy, 126 East Main Street, Newbern, TN 38059, 888-658-6200	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.	Main Street Family Pharmacy, LLC / 3 units	Class II	Terminated
D-041-2014	05-28-2013	Ascorbic Acid 500mg/ml 50ml, Main Street Compounding Pharmacy, 126 East Main Street, Newbern, TN 38059, 888-658-6200	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.	Main Street Family Pharmacy, LLC / 894 units	Class II	Terminated
D-313-2014	05-28-2013	Triamcinolone PF 40mg 2ml, Main Street Compounding Pharmacy, 126 East Main Street, Newbern, TN 38059, 888-658-6200	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.	Main Street Family Pharmacy, LLC / 4 units	Class II	Terminated
D-089-2014	05-28-2013	Estradiol Pellets 10mg, Main Street Compounding Pharmacy, 126 East Main Street, Newbern, TN 38059, 888-658-6200	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.	Main Street Family Pharmacy, LLC / 250 units	Class II	Terminated
D-210-2014	05-28-2013	Methylprednisolone 100mg/ml, 10ml, Main Street Compounding Pharmacy, 126 East Main Street, Newbern, TN 38059, 888-658-6200	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.	Main Street Family Pharmacy, LLC / 697 units	Class I	Terminated
D-137-2014	05-28-2013	HCG 350 iu prefilled syringes, Main Street Compounding Pharmacy, 126 East Main Street, Newbern, TN 38059, 888-658-6200	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.	Main Street Family Pharmacy, LLC / 12757 units	Class II	Terminated
D-107-2014	05-28-2013	HCG 11000u w/B-12, Main Street Compounding Pharmacy, 126 East Main Street, Newbern, TN 38059, 888-658-6200	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.	Main Street Family Pharmacy, LLC / 36 units	Class II	Terminated
D-253-2014	05-28-2013	Phosphatidylcholine/Deoxycholic Acid 50ml, Main Street Compounding Pharmacy, 126 East Main Street, Newbern, TN 38059, 888-658-6200	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.	Main Street Family Pharmacy, LLC / 11 units	Class II	Terminated
D-193-2014	05-28-2013	Marcaine .1% NS 300ml pump, Main Street Compounding Pharmacy, 126 East Main Street, Newbern, TN 38059, 888-658-6200	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.	Main Street Family Pharmacy, LLC / 1 unit	Class II	Terminated
D-173-2014	05-28-2013	Lipo X 50ml, Main Street Compounding Pharmacy, 126 East Main Street, Newbern, TN 38059, 888-658-6200	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.	Main Street Family Pharmacy, LLC / 85 units	Class II	Terminated
D-309-2014	05-28-2013	Tetracaine 2%, Main Street Compounding Pharmacy, 126 East Main Street, Newbern, TN 38059, 888-658-6200	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.	Main Street Family Pharmacy, LLC / 3 units	Class II	Terminated
D-119-2014	05-28-2013	HCG 210 iu prefilled syringes, Main Street Compounding Pharmacy, 126 East Main Street, Newbern, TN 38059, 888-658-6200	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.	Main Street Family Pharmacy, LLC / 56 units	Class II	Terminated
D-162-2014	05-28-2013	Lidocaine 1% 30ml (PF), Main Street Compounding Pharmacy, 126 East Main Street, Newbern, TN 38059, 888-658-6200	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.	Main Street Family Pharmacy, LLC / 56 units	Class II	Terminated
D-124-2014	05-28-2013	HCG 250 iu prefilled syringes, Main Street Compounding Pharmacy, 126 East Main Street, Newbern, TN 38059, 888-658-6200	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.	Main Street Family Pharmacy, LLC / 5777 units	Class II	Terminated
D-297-2014	05-28-2013	Testosterone Pellet 12.5mg, Main Street Compounding Pharmacy, 126 East Main Street, Newbern, TN 38059, 888-658-6200	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.	Main Street Family Pharmacy, LLC / 16 units	Class II	Terminated
D-235-2014	05-28-2013	Mic Ultra 10ml, Main Street Compounding Pharmacy, 126 East Main Street, Newbern, TN 38059, 888-658-6200	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.	Main Street Family Pharmacy, LLC / 76 units	Class II	Terminated
D-317-2014	05-28-2013	Triamcinolone Acetonide 40mg/ml, Main Street Compounding Pharmacy, 126 East Main Street, Newbern, TN 38059, 888-658-6200	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.	Main Street Family Pharmacy, LLC / 66 units	Class II	Terminated
D-218-2014	05-28-2013	Methylprednisolone 40mg w/lidocaine 1ml, Main Street Compounding Pharmacy, 126 East Main Street, Newbern, TN 38059, 888-658-6200	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.	Main Street Family Pharmacy, LLC / 247 units	Class II	Terminated
D-203-2014	05-28-2013	Medroxyprogesterone 150mg w/lid, 1ml Main Street Compounding Pharmacy, 126 East Main Street, Newbern, TN 38059, 888-658-6200	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.	Main Street Family Pharmacy, LLC / 4 units	Class II	Terminated
D-125-2014	05-28-2013	HCG 2500u, Main Street Compounding Pharmacy, 126 East Main Street, Newbern, TN 38059, 888-658-6200	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.	Main Street Family Pharmacy, LLC / 41 units	Class II	Terminated
D-252-2014	05-28-2013	Oral B-12 30ml--cotton candy, Main Street Compounding Pharmacy, 126 East Main Street, Newbern, TN 38059, 888-658-6200	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.	Main Street Family Pharmacy, LLC / 82 units	Class II	Terminated
D-078-2014	05-28-2013	Dexamethasone LA 16mg 30ml, Main Street Compounding Pharmacy, 126 East Main Street, Newbern, TN 38059, 888-658-6200	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.	Main Street Family Pharmacy, LLC / 6 units	Class II	Terminated
D-312-2014	05-28-2013	Triamcinolone Diacetate 40mg 5ml, Main Street Compounding Pharmacy, 126 East Main Street, Newbern, TN 38059, 888-658-6200	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.	Main Street Family Pharmacy, LLC / 48 units	Class II	Terminated
D-051-2014	05-28-2013	B-Complex 206 mg/ml 30ml, Main Street Compounding Pharmacy, 126 East Main Street, Newbern, TN 38059, 888-658-6200	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.	Main Street Family Pharmacy, LLC / 1 unit	Class II	Terminated
D-230-2014	05-28-2013	Mic 30ml, Main Street Compounding Pharmacy, 126 East Main Street, Newbern, TN 38059, 888-658-6200	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.	Main Street Family Pharmacy, LLC / 16 units	Class II	Terminated
D-260-2014	05-28-2013	Pre-menopausal HCG PK 2nd month, Main Street Compounding Pharmacy, 126 East Main Street, Newbern, TN 38059, 888-658-6200	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.	Main Street Family Pharmacy, LLC / 58 units	Class II	Terminated
D-195-2014	05-28-2013	Marcaine .1%/NS 450ml, Main Street Compounding Pharmacy, 126 East Main Street, Newbern, TN 38059, 888-658-6200	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.	Main Street Family Pharmacy, LLC / 24 units	Class II	Terminated
D-298-2014	05-28-2013	Testosterone Pellet 87.5mg, Main Street Compounding Pharmacy, 126 East Main Street, Newbern, TN 38059, 888-658-6200	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.	Main Street Family Pharmacy, LLC / 24 units	Class II	Terminated
D-295-2014	05-28-2013	Testosterone Pellet 112.5mg, Main Street Compounding Pharmacy, 126 East Main Street, Newbern, TN 38059, 888-658-6200	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.	Main Street Family Pharmacy, LLC / 20 units	Class II	Terminated
D-172-2014	05-28-2013	Lipo C 30ml, Methionine 12.5mg, Inositol 50mg, Choline 100mg, Methylcobalamin 1mg, L-Carnitine 200mg, Main Street Compounding Pharmacy, 126 East Main Street, Newbern, TN 38059, 888-658-6200	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.	Main Street Family Pharmacy, LLC / 23 units	Class II	Terminated
D-064-2014	05-28-2013	Brompheniramine 10ml, Main Street Compounding Pharmacy, 126 East Main Street, Newbern, TN 38059, 888-658-6200	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.	Main Street Family Pharmacy, LLC / 415 units	Class II	Terminated
D-128-2014	05-28-2013	HCG 275 iu prefilled syringes, Main Street Compounding Pharmacy, 126 East Main Street, Newbern, TN 38059, 888-658-6200	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.	Main Street Family Pharmacy, LLC / 165 units	Class II	Terminated
D-196-2014	05-28-2013	Marcaine .2% NS 300ml, Main Street Compounding Pharmacy, 126 East Main Street, Newbern, TN 38059, 888-658-6200	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.	Main Street Family Pharmacy, LLC / 233 units	Class II	Terminated
D-097-2014	05-28-2013	Glutathione "Reduced" 200mg/ml, Main Street Compounding Pharmacy, 126 East Main Street, Newbern, TN 38059, 888-658-6200	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.	Main Street Family Pharmacy, LLC / 19 units	Class II	Terminated
D-201-2014	05-28-2013	Medroxyprogesterone 150mg 1ml, Main Street Compounding Pharmacy, 126 East Main Street, Newbern, TN 38059, 888-658-6200	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.	Main Street Family Pharmacy, LLC / 1131 units	Class II	Terminated
D-231-2014	05-28-2013	Mic B w/Amp Mix, 50ml Main Street Compounding Pharmacy, 126 East Main Street, Newbern, TN 38059, 888-658-6200	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.	Main Street Family Pharmacy, LLC / 36 units	Class II	Terminated
D-322-2014	05-28-2013	Wydase 5ml, Main Street Compounding Pharmacy, 126 East Main Street, Newbern, TN 38059, 888-658-6200	Lack of Assurance of Sterility	Main Street Family Pharmacy, LLC / 50 units	Class II	Terminated
D-247-2014	05-28-2013	Mitomycin 2ml (full Strength), Main Street Compounding Pharmacy, 126 East Main Street, Newbern, TN 38059, 888-658-6200	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.	Main Street Family Pharmacy, LLC / 32 units	Class II	Terminated
D-176-2014	05-28-2013	Lipotonix Plus 30ml, Main Street Compounding Pharmacy, 126 East Main Street, Newbern, TN 38059, 888-658-6200	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.	Main Street Family Pharmacy, LLC / 1505 units	Class II	Terminated
D-038-2014	05-28-2013	Amikacin 500mg 2ml, Main Street Compounding Pharmacy, 126 East Main Street, Newbern, TN 38059, 888-658-6200	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.	Main Street Family Pharmacy, LLC / 744 units	Class II	Terminated
D-090-2014	05-28-2013	Estradiol Pellets 12.5mg, Main Street Compounding Pharmacy, 126 East Main Street, Newbern, TN 38059, 888-658-6200	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.	Main Street Family Pharmacy, LLC / 334 units	Class II	Terminated
D-025-2014	05-28-2013	Acetylcystein 10% 120ml, Main Street Compounding Pharmacy, 126 East Main Street, Newbern, TN 38059, 888-658-6200	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.	Main Street Family Pharmacy, LLC / 1 unit	Class II	Terminated
D-088-2014	05-28-2013	Estradiol Pellet 50mg, Main Street Compounding Pharmacy, 126 East Main Street, Newbern, TN 38059, 888-658-6200	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.	Main Street Family Pharmacy, LLC / 4 units	Class II	Terminated
D-185-2014	05-28-2013	Lipotropic 2ml PFS, Main Street Compounding Pharmacy, 126 East Main Street, Newbern, TN 38059, 888-658-6200	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.	Main Street Family Pharmacy, LLC / 6 units	Class II	Terminated
D-294-2014	05-28-2013	Testosterone Cypionate 300mg/ml, 10ml Main Street Compounding Pharmacy, 126 East Main Street, Newbern, TN 38059, 888-658-6200	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.	Main Street Family Pharmacy, LLC / 1 vial	Class II	Terminated
D-299-2014	05-28-2013	Testosterone Pellets 100mg, Main Street Compounding Pharmacy, 126 East Main Street, Newbern, TN 38059, 888-658-6200	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.	Main Street Family Pharmacy, LLC / 21981 units	Class II	Terminated
D-098-2014	05-28-2013	Glutathione 150mg/ml 30ml, Main Street Compounding Pharmacy, 126 East Main Street, Newbern, TN 38059, 888-658-6200	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.	Main Street Family Pharmacy, LLC / 1 unit	Class II	Terminated
D-236-2014	05-28-2013	Mic Ultra 30ml, Main Street Compounding Pharmacy, 126 East Main Street, Newbern, TN 38059, 888-658-6200	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.	Main Street Family Pharmacy, LLC / 680 units	Class II	Terminated
D-043-2014	05-28-2013	B-12 (Methyl) 30ml, Main Street Compounding Pharmacy, 126 East Main Street, Newbern, TN 38059, 888-658-6200	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.	Main Street Family Pharmacy, LLC / 7 units	Class II	Terminated
D-129-2014	05-28-2013	HCG 280 iu prefilled syringes, Main Street Compounding Pharmacy, 126 East Main Street, Newbern, TN 38059, 888-658-6200	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.	Main Street Family Pharmacy, LLC / 2873 units	Class II	Terminated
D-305-2014	05-28-2013	Testosterone Pellets 37.5mg, Main Street Compounding Pharmacy, 126 East Main Street, Newbern, TN 38059, 888-658-6200	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.	Main Street Family Pharmacy, LLC / 18 units	Class II	Terminated
D-033-2014	05-28-2013	Alprostadil 40mg, Main Street Compounding Pharmacy, 126 East Main Street, Newbern, TN 38059, 888-658-6200	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.	Main Street Family Pharmacy, LLC / 1 unit	Class II	Terminated
D-029-2014	05-28-2013	Adenosine Monophosphate, 50mg/ml 30ml, Main Street Compounding Pharmacy, 126 East Main Street, Newbern, TN 38059, 888-658-6200	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.	Main Street Family Pharmacy, LLC / 15 units	Class II	Terminated
D-165-2014	05-28-2013	Lincomycin 300 (PF) 10ml, Main Street Compounding Pharmacy, 126 East Main Street, Newbern, TN 38059, 888-658-6200	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.	Main Street Family Pharmacy, LLC / 1516 units	Class II	Terminated
D-234-2014	05-28-2013	Mic Combo w/methyl 30ml, Main Street Compounding Pharmacy, 126 East Main Street, Newbern, TN 38059, 888-658-6200	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.	Main Street Family Pharmacy, LLC / 2 units	Class II	Terminated
D-184-2014	05-28-2013	Lipotropic 1ml PFS, Main Street Compounding Pharmacy, 126 East Main Street, Newbern, TN 38059, 888-658-6200	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.	Main Street Family Pharmacy, LLC / 147 units	Class II	Terminated
D-068-2014	05-28-2013	Carnitine 250mg/ml, Main Street Compounding Pharmacy, 126 East Main Street, Newbern, TN 38059, 888-658-6200	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.	Main Street Family Pharmacy, LLC / 30 units	Class II	Terminated
D-228-2014	05-28-2013	Mic 25/50/50 50ml, Main Street Compounding Pharmacy, 126 East Main Street, Newbern, TN 38059, 888-658-6200	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.	Main Street Family Pharmacy, LLC / 6 units	Class II	Terminated
D-263-2014	05-28-2013	Sermorelin 6mg, Main Street Compounding Pharmacy, 126 East Main Street, Newbern, TN 38059, 888-658-6200	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.	Main Street Family Pharmacy, LLC / 706 units	Class II	Terminated
D-141-2014	05-28-2013	HCG 390iu prefilled syringes, Main Street Compounding Pharmacy, 126 East Main Street, Newbern, TN 38059, 888-658-6200	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.	Main Street Family Pharmacy, LLC / 604 units	Class II	Terminated
D-200-2014	05-28-2013	Medroxyprogesterone 150mg 10ml, Main Street Compounding Pharmacy, 126 East Main Street, Newbern, TN 38059, 888-658-6200	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.	Main Street Family Pharmacy, LLC / 5 units	Class II	Terminated
D-039-2014	05-28-2013	Aminophylline 250mg 10ml, Main Street Compounding Pharmacy, 126 East Main Street, Newbern, TN 38059, 888-658-6200	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.	Main Street Family Pharmacy, LLC / 6 units	Class II	Terminated
D-080-2014	05-28-2013	Double Strength PGE1 40mcg 2ml, Main Street Compounding Pharmacy, 126 East Main Street, Newbern, TN 38059, 888-658-6200	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.	Main Street Family Pharmacy, LLC / 1 unit	Class II	Terminated
D-133-2014	05-28-2013	HCG 310 iu prefilled syringes, Main Street Compounding Pharmacy, 126 East Main Street, Newbern, TN 38059, 888-658-6200	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.	Main Street Family Pharmacy, LLC / 7080 units	Class II	Terminated
D-111-2014	05-28-2013	HCG 15000u w/b-12, Main Street Compounding Pharmacy, 126 East Main Street, Newbern, TN 38059, 888-658-6200	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.	Main Street Family Pharmacy, LLC / 1 unit	Class II	Terminated
D-122-2014	05-28-2013	HCG 230 iu prefilled syringes, Main Street Compounding Pharmacy, 126 East Main Street, Newbern, TN 38059, 888-658-6200	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.	Main Street Family Pharmacy, LLC / 231 units	Class II	Terminated
D-024-2014	05-28-2013	17-P 1ml, Main Street Compounding Pharmacy, 126 East Main Street, Newbern, TN 38059, 888-658-6200	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.	Main Street Family Pharmacy, LLC / 875 units	Class II	Terminated
D-249-2014	05-28-2013	Mitomycin 40mg Compounded, Main Street Compounding Pharmacy, 126 East Main Street, Newbern, TN 38059, 888-658-6200	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.	Main Street Family Pharmacy, LLC / 10 units	Class II	Terminated
D-109-2014	05-28-2013	HCG 140 iu prefilled syringes, Main Street Compounding Pharmacy, 126 East Main Street, Newbern, TN 38059, 888-658-6200	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.	Main Street Family Pharmacy, LLC / 3 units	Class II	Terminated
D-031-2014	05-28-2013	Alprostadil 100mcg/ml 10ml, Main Street Compounding Pharmacy, 126 East Main Street, Newbern, TN 38059, 888-658-6200	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.	Main Street Family Pharmacy, LLC / 8 units	Class II	Terminated
D-606-2013	05-28-2013	Actiq (oral transmucosal fentanyl citrate) 200 mcg, lozenge on a stick, a)Single Blister (NDC 63459-502-01), b) 30 count carton (NDC 63459-502-30), Rx only, Manufactured by: Cephalon, Inc., Salt Lake City, UT 84116	Failed Dissolution Specification; during stability testing	Teva Pharmaceuticals USA, Inc. / 316 cartons	Class II	Terminated
D-912-2013	05-27-2013	Eyebright Concentrate Topical Eye Rinse, 1, 2, 4, 8, 16 & 32 fl oz bottles, Produced and distributed by: Wise Woman Herbals, Creswell, OR	Lack of Assurance of Sterility; Lack of Assurance of Sterility; product not manufactured under sterile conditions as required for ophthalmic drug products	Earthlabs, Inc. DBA Wise Woman Herbals / 581x1oz bottles, 263x2 oz bottles, 20x4 oz bottles, 2x8 oz bottles, 1x16 oz bottle, 1x32 oz bottle	Class II	Terminated
D-920-2013	05-25-2013	Magnesium Sulfate Injection, USP, 50% (25 grams/50 mL), For IM or IV Use, 50 mL, Single Dose Vial, Rx only, Preservative Free, APP Pharmaceuticals, LLC, Schaumburg, IL, 60173, NDC 63323-064-50	Presence of Particulate Matter: Glass particulate matter was observed in a retention sample during an annual review.	Fresenius Kabi USA, LLC / 15,625 vials	Class I	Terminated
D-887-2013	05-25-2013	Propofol Injectable Emulsion, 1%, 1 g/100 mL (10 mg/mL), 100 mL, Single patient infusion vial, RX only, Hospira, Inc., Lake Forest, IL 60045, NDC 0409-4699-24; Propofol Injectable Emulsion, 500 mg/50 mL, 50 mL, Single patient infusion vial, RX only, Hospira, Inc., Lake Forest, IL 60045, NDC 0409-4699-33 Package NDCs: 0409-4699-50; 0409-4699-30; 0409-4699-53; 0409-4699-33; 0409-4699-54; 0409-4699-24; 0409-6010-02; 0409-6010-25; 0409-1511-97; 0409-1511-98; 0409-0501-97; 0409-0501-98; 0409-0010-97; 0409-0010-98	Presence of Particulate Matter; single visible particulate was identified during a retain sample inspection identified as stainless steel	Hospira Inc. / 94,110 vials	Class II	Terminated
D-622-2013	05-23-2013	INK-EEZE Tattoo Black Label Numbing Spray, a) 0.27 oz. (8 mL), b) 2 oz. (59 mL), No Epinephrine, Active Ingredients: Lidocaine HCl 5% Topical Anesthetic, Distributed by: Indelicare, LLC 914 Tourmaline Drive, Newbury Park, CA 91320, (800) 611-7720, www.inkeeze.com.	Marketed without an approved NDA/ANDA: INK-EEZE Tattoo Numbing Spray contains 5% Lidocaine and is being marketed without an approved NDA/ANDA. Lidocaine 5% is an ingredient in many FDA approved products, making Ink-Eeze an unapproved new drug.	Indelicare LLC / 2849 Bottles	Class II	Terminated
D-621-2013	05-23-2013	INK-EEZE Tattoo Numbing Spray, 2 oz. (59 mL), Active Ingredients: Lidocaine HCl 5% Topical Anesthetic, Distributed by: Indelicare, LLC 914 Tourmaline Drive, Newbury Park, CA 91320, (800) 611-7720, www.inkeeze.com	Marketed without an approved NDA/ANDA: INK-EEZE Tattoo Numbing Spray contains 5% Lidocaine and is being marketed without an approved NDA/ANDA. Lidocaine 5% is an ingredient in many FDA approved products, making Ink-Eeze an unapproved new drug.	Indelicare LLC / 683 Bottles	Class II	Terminated
D-856-2013	05-21-2013	Zolpidem Tartrate Tablets 5 mg, 10 tablets per blister, 10 blisters per carton, 100 cartons per box, Rx Only, Manufactured for Wockhardt USA LLC., Parsippany, NJ 07054 by Wockhardt Limited, Mumbai, India, NDC 68084-225-01	Unit Dose Mispackaging: This recall event is due to a random undetected packaging issue which could increase the potential for a small number of individual unit dose blisters to be packed with more than one tablet.	American Health Packaging / 48.230 carton units	Class II	Terminated
D-688-2013	05-21-2013	Folic Acid Injection, USP, 5 mg/mL, For IM, IV or SC Use, 10 mL, Multiple Dose Vial, Rx only, APP Pharmaceuticals, LLC, Schaumburg, IL 60173, NDC 63323-184-11	Failed Impurities/Degradation Specification	Fresenius Kabi USA, LLC / 80,480 vials	Class III	Terminated
D-687-2013	05-21-2013	Nimodipine Capsules 30 mg, Rx Only, For Institutional Use Only, a) 30-count unit dose Capsules (5x6 blister cards per carton), NDC 57664-135-64, b) 100-count unit dose Capsules (25x4 blister cards per carton), NDC 57664-135-65, Distributed by: Caraco Pharmaceutical Laboratories, Ltd. Detroit, MI 48202 Affiliate of Sun Pharmaceutical Industries, Inc.	Crystallization; crystallized nimodipine	Sun Pharmaceutical Industries Inc. / 46387 Cartons	Class II	Terminated
D-627-2013	05-21-2013	Lidocaine Hydrochloride and 5% Dextrose Injection, USP, 2g VIAFLEX Plus Plastic Container, 500mL, Rx Only, Baxter, Deerfield, IL 60015	Lack of Assurance of Sterilty: Specific lot numbers of these products have been identified for potential administration port leakage. The potential for leakage is the result of a manufacturing issue which occurred during the sealing of the closure assembly at the administration port.	Baxter Healthcare Corp. / N/A	Class II	Terminated
D-625-2013	05-21-2013	5% Dextrose Injection, USP, in VIAFLEX Plastic Container Multi Pack, Rx Only, a) 50 mL (NDC 0338-0017-31), b) 100 mL (NDC 0338-0017-38), Baxter, Deerfield, IL 60015 Package NDCs: 0338-0017-10; 0338-0017-41; 0338-0017-11; 0338-0017-31; 0338-0017-48; 0338-0017-18; 0338-0017-38; 0338-0017-02; 0338-0017-03; 0338-0017-04; 0338-0023-02; 0338-0023-03; 0338-0023-04	Lack of Assurance of Sterility: Specific lot numbers of these products have been identified for potential administration port leakage. The potential for leakage is the result of a manufacturing issue which occurred during the sealing of the closure assembly at the administration port.	Baxter Healthcare Corp. / 730,848 units	Class II	Terminated
D-626-2013	05-21-2013	Heparin Sodium and 0.9% Sodium Chloride Injection, a) Product code 2B0944, 2000 USP Units, Viaflex Plus Container, 1000mL, (NDC 0338-0433-04), b) Product code 2B0953: 1000 USP Units, Viaflex Plus Container, 500 mL (NDC 0338-0431-03), Baxter, Deerfield, IL 60015 Package NDCs: 0338-0431-03; 0338-0433-04; 0338-0424-18; 0338-0428-12	Lack of Assurance of Sterility: Specific lot numbers of these products have been identified for potential administration port leakage. The potential for leakage is the result of a manufacturing issue which occurred during the sealing of the closure assembly at the administration port.	Baxter Healthcare Corp. / N/A	Class II	Terminated
D-624-2013	05-21-2013	0.9% Sodium Chloride Injection, USP, in MINI-BAG Plus Container, a) 50 mL (NDC 0338-0553-11), b) 100 mL (NDC 0338-0553-18), Rx Only, Baxter, Deerfield, IL 60015 Package NDCs: 0338-0553-11; 0338-0553-18	Lack of Assurance of Sterility: Specific lot numbers of these products have been identified for potential administration port leakage. The potential for leakage is the result of a manufacturing issue which occurred during the sealing of the closure assembly at the administration port.	Baxter Healthcare Corp. / 845,520 units	Class II	Terminated
D-629-2013	05-21-2013	Metronidazole Injection USP, RTU, 500 mg/100mL in Viaflex Plus Container, Baxter, Deerfield, IL 60015, NDC 0338-1055-48 Package NDCs: 0338-1055-48	Lack of Assurance of Sterility: Specific lot numbers of these products have been identified for potential administration port leakage. The potential for leakage is the result of a manufacturing issue which occurred during the sealing of the closure assembly at the administration port.	Baxter Healthcare Corp. / 172,296 units	Class II	Terminated
D-628-2013	05-21-2013	Sodium Chloride Injection, USP, a) Product code 2B1301- 50 mL in Viaflex Container Quad Pack (NDC 0338-0049-11); b) 2B1302- 100mL in Viaflex Quad Pack (NDC 0338-0049-18); c) 2B1306- 50 mL in Viaflex Single Pack (NDC 0338-0049-41; d) 2B1307- 100mL in Viaflex Single Pack (NDC 0338-0049-48); e) 2B1308- 50 ML in Viaflex Multi Pack (NDC 0338-0049-31); f) 2B1309- 100mL in Viaflex Multi Pack (NDC 0338-0049-38), Rx Only, Baxter, Deerfield, IL 60015 Package NDCs: 0338-0049-01; 0338-0049-02; 0338-0049-03; 0338-0049-04; 0338-0049-10; 0338-0049-41; 0338-0049-11; 0338-0049-31; 0338-0049-48; 0338-0049-18; 0338-0049-38; 0338-0043-03; 0338-0043-04	Lack of Assurance of Sterility: Specific lot numbers of these products have been identified for potential administration port leakage. The potential for leakage is the result of a manufacturing issue which occurred during the sealing of the closure assembly at the administration port.	Baxter Healthcare Corp. / 1,788,292 units	Class II	Terminated
D-851-2013	05-20-2013	Ondansetron Injection, USP, 4mg/2mL, (2mg/ml), 2mL single-dose Fliptop Vial, Rx only, Sterile, NDC 0409-4755-03, Hospira, Inc, Lake Forest, IL 60045. Package NDCs: 0409-4755-18; 0409-4755-03; 0409-4759-01	Presence of Particulate; lot being recalled as a precaution due to the discovery of 2 particles found in a lot which preceded the recalled lot	Hospira, Inc. / 340,600 vials	Class II	Terminated
D-1250-2014	05-20-2013	XIYOUJI QINGZHI CAPSULE, 300mg, 20 count box	Marketed without an Approved NDA/ANDA: Products found to contain undeclared sibutramine. Sibutramine was removed from the U.S. market for safety reasons, making these products unapproved new drugs.	Dolphin Intertrade Corporation / 8 bottles	Class I	Terminated
D-1249-2014	05-20-2013	JaDera, 100% Natural Weight Loss Supplement, capsules, 30 count bottle	Marketed without an Approved NDA/ANDA: Products found to contain undeclared sibutramine. Sibutramine was removed from the U.S. market for safety reasons, making these products unapproved new drugs.	Dolphin Intertrade Corporation / 998 boxes	Class I	Terminated
D-832-2013	05-20-2013	Methotrexate Injection, USP, Preservative-Free, 1 g/40 mL (25 mg/mL), 40 mL Single Dose Vial, Rx only, Manufactured for: Sandoz Inc., Princeton, NJ 08540; Manufactured by: EBEWE Pharma Ges.m.b.H. Nfg.KG, A-4866 Unterach, AUSTRIA, NDC 66758-041-01.	Presence of Particulate Matter: Found during examination of retention samples.	Sandoz Incorporated / 1,635 vials	Class I	Terminated
D-822-2013	05-17-2013	Enablex (darifenacin) Extended Release Tablet, 15 mg per tablet. Physician Sample 7 Tablets bottle, Rx only, Mfd by: Novartis Pharma Stein AG, Stein, Switzerland, NDC 0078-9420-07	Failed Impurities/Degradation Specifications: unspecified degradation product	Warner Chilcott US LLC / 188,600 bottles	Class II	Terminated