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 August 07, 2026 and include a total of 17860 recall reports.

Recall Number	Recall Initiation Date	Product Description	Recall Reason	Recall Firm / Quantity	Recall Classification	Status
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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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	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-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-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-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-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-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-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-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-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-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-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
D-824-2013	05-16-2013	West-ward Belladonna Alkaloids with Phenobarbital Tablets, a) 1000-count bottle (NDC 0143-1140-10), b) 5000-count bottle (NDC 0143-1140-51), Rx only, Manufactured by West-ward Pharmaceutical Corp., Eatontown, N.J., 07724	Presence of Foreign Substance: Belladonna Alkaloids with Phenobarbital Tablets with black specks comprised of degraded organic material on tablets.	West-Ward Pharmaceutical Corp. / 14,503 bottles	Class II	Terminated
D-825-2013	05-16-2013	West-ward Belladonna Alkaloids with Phenobarbital Tablets, a) 1000-count bottle (NDC 0143-1140-10),Rx only, Manufactured by West-ward Pharmacuetical Corp., Eatontown, N.J., 07724	Cross contamination with other products: Belladonna Alkaloids with Phenobarbital Tablets contained a trace amount of Methocarbamol.	West-Ward Pharmaceutical Corp. / 7,324 bottles	Class II	Terminated
D-501-2013	05-16-2013	Diazepam Injection, USP 5 mg/mL, 10 mL, Multiple-dose fliptop vial, RX only, HOSPIRA, INC. LAKE FOREST, IL 60045 USA, NDC 0409-3213-12 Package NDCs: 0409-3213-11; 0409-3213-12	Lack of Assurance of Sterility: Loose crimp applied to the fliptop vial.	Hospira Inc. / 95,700 vials	Class II	Terminated
D-588-2013	05-15-2013	Proplete 60 - 69 KG (Intradialytic Parenteral Nutrition - dialysate solution with added amino acids), in 555mL bag, Pentec Health Inc, 4 Creek Parkway Suite A Boothwyn, PA 19061-3132	Lack of Assurance of Sterility: Sterility could not be assured for compounded sterile renal nutritional prescriptions.	Pentec Health / 59 Bags	Class II	Terminated
D-584-2013	05-15-2013	Fresenius bag 1% Amino Acids (Intraperitoneal Parenteral Nutrition - dialysate solution with added amino acids), 1000mL bag, Pentec Health Inc., 4 Creek Parkway Suite A, Boothwyn, PA 19061-3132	Lack of Assurance of Sterility: Sterility could not be assured for compounded sterile renal nutritional prescriptions	Pentec Health / 1 Bag	Class II	Terminated
D-593-2013	05-15-2013	Baxter LL bag 1% Amino Acids w/KCL (Intraperitoneal Parenteral Nutrition - dialysate solution with added amino acids and KCL), in 3000mL bag, Pentec Health Inc., 4 Creek Parkway Suite A, Boothwyn, PA 19061-3132	Lack of Assurance of Sterility: Sterility could not be assured for compounded sterile renal nutritional prescriptions.	Pentec Health / 1 Bag	Class II	Terminated
D-592-2013	05-15-2013	Proplete 45 - 51 KG (Intraperitoneal Parenteral Nutrition - dialysate solution with added amino acids), in 435mL bag, Pentec Health Inc., 4 Creek Parkway Suite A Boothwyn, PA 19061-3132	Lack of Assurance of Sterility: Sterility could not be assured for compounded sterile renal nutritional prescriptions.	Pentec Health / 4 Bags	Class II	Terminated
D-581-2013	05-15-2013	Proplete 34 - 39 KG (Intradialytic Parenteral Nutrition composed of amino acids, dextrose and sterile water), in 330mL bag, Pentec Health Inc., 4 Creek Parkway Suite A, Boothwyn, PA 19061-13132	Lack of Assurance of Sterility: Sterility could not be assured for compounded sterile renal nutritional prescriptions.	Pentec Health / 1 Bag	Class II	Terminated
D-590-2013	05-15-2013	Proplete 80+ KG (Intraperitoneal Parenteral Nutrition - dialysate solution with added amino acids), in 710mL bag, Pentec Health Inc., 4 Creek Parkway Suite A Boothwyn, PA 19061-3132	Lack of Assurance of Sterility: Sterility could not be assured for compounded sterile renal nutritional prescriptions.	Pentec Health / 1 Bag	Class II	Terminated
D-582-2013	05-15-2013	Baxter Ultrabag 1.5% Amino Acids (Intraperitoneal Parenteral Nutrition - dialysate solution with added amino acids), in a) 1500mL and b) 3000mL bags. Pentec Health Inc., 4 Creek Parkway Suite A, Boothwyn, PA 19061-3132	Lack of Assurance of Sterility: Sterility could not be assured for compounded sterile renal nutritional prescriptions.	Pentec Health / 3 units	Class II	Terminated
D-583-2013	05-15-2013	Baxter LL bag 1% Amino Acids (Intraperitoneal Parenteral Nutrition - dialysate solution with added amino acids), in a) 3000mL bag, b) 5000mL bag and c) 6000mL bag, Pentec Health Inc., 4 Creek Parkway Suite A, Boothwyn, PA 19061-3132	Lack of Assurance of Sterility: Sterility could not be assured for compounded sterile renal nutritional prescriptions.	Pentec Health / 5 Bags	Class II	Terminated
D-585-2013	05-15-2013	IDPN (Intradialytic Parenteral Nutrition - dialysate solution with added amino acids), a) 490mL bag, b) 500mL bag, and c) 590mL bag, Pentec Health Inc., 4 Creek Parkway Suite A, Boothwyn, PA 19061-3132	Lack of Assurance of Sterility: Sterility could not be assured for compounded sterile renal nutritional prescriptions.	Pentec Health / 3 Bags	Class II	Terminated
D-595-2013	05-15-2013	Baxter LL bag 2% Amino Acids (Intraperitoneal Parenteral Nutrition - dialysate solution with added amino acids), in a) 2500mL bag and b) 6000mL bag, Pentec Health Inc., 4 Creek Parkway Suite A, Boothwyn, PA 19061-3132	Lack of Assurance of Sterility: Sterility could not be assured for compounded sterile renal nutritional prescriptions.	Pentec Health / 3 Bags	Class II	Terminated
D-829-2013	05-15-2013	Ranitidine Syrup (Ranitidine Oral Solution USP) 15 mg/mL, Rx Only. Manufactured by VistaPharm, Inc., Birmingham, AL 35242. Distributed by Actavis Mid Atlantic LLC 1877 Kawai Road, Lincolnton, NC 28092 USA	Failed Impurity/Degradation Specification; "Related Compound C"	Actavis South Atlantic LLC / A total of 133,968 bottles (units)	Class II	Terminated
D-587-2013	05-15-2013	Proplete 52 - 59 KG (Intradialytic Parenteral Nutrition - dialysate solution with added amino acids), in a) 485mL bag and b) 490mL bag, Pentec Health Inc 4 Creek Parkway Suite A Boothwyn, PA 19061-3132	Lack of Assurance of Sterility: Sterility could not be assured for compounded sterile renal nutritional prescriptions.	Pentec Health / 25 Bags	Class II	Terminated
D-591-2013	05-15-2013	Proplete 90+ KG (Intraperitoneal Parenteral Nutrition - dialysate solution with added amino acids), in 805mL bag, Pentec Health Inc., 4 Creek Parkway Suite A Boothwyn, PA 19061-3132	Lack of Assurance of Sterility: Sterility could not be assured for compounded sterile renal nutritional prescriptions.	Pentec Health / 1 Bag	Class II	Terminated
D-594-2013	05-15-2013	Baxter LL bag 1.5% Amino Acids (Intraperitoneal Parenteral Nutrition - dialysate solution with added amino acids), in a) 1000mL bag, b) 2000mL bag, c) 2500mL bag, d) 5000mL bag, and e) 6000mL bag, Pentec Health Inc., 4 Creek Parkway Suite A, Boothwyn, PA 19061-3132	Lack of Assurance of Sterility: Sterility could not be assured for compounded sterile renal nutritional prescriptions.	Pentec Health / 8 Bags	Class II	Terminated
D-586-2013	05-15-2013	Proplete 40 - 44 KG (Intradialytic Parenteral Nutrition - dialysate solution with added amino acids), in a) 385mL and b) 390mL, Pentec Health Inc 4 Creek Parkway Suite A Boothwyn, PA 19061-3132	Lack of Assurance of Sterility: Sterility could not be assured for compounded sterile renal nutritional prescriptions.	Pentec Health / 9 Bags	Class II	Terminated
D-589-2013	05-15-2013	Proplete 70+ KG (Intraperitoneal Parenteral Nutrition - dialysate solution with added amino acids), in a) 635mL bag and b) 660mL bag, Pentec Health Inc 4 Creek Parkway Suite A Boothwyn, PA 19061-3132	Lack of Assurance of Sterility: Sterility could not be assured for compounded sterile renal nutritional prescriptions	Pentec Health / 38 Bags	Class II	Terminated
D-452-2013	05-15-2013	Budesonide Capsules, 3 mg, Enteric Coated, packaged in 30-count capsules unit dose (3 x 10 capsules blister packaged) per box, Rx only, Manufactured by: Mylan Pharmaceuticals Inc., Morgantown, WV 26505; Packaged and Distributed by: UDL Laboratories, Inc., Rockford, IL 61103, NDC 51079-020-03.	Failed Dissolution Specifications: Routine stability testing at the 12-month interval yielded an out-of-specification (OOS) result for dissolution testing.	Mylan Institutional, Inc. (d.b.a. UDL Laboratories) / 1,621 boxes	Class III	Terminated
D-740-2014	05-15-2013	Maximum Strength Comtrex , Day/Night Flu Therapy , Acetaminophen 325mg, Chlorpheniramine Maleate 2mg, Dextromethorphan HBr 10mg, Phenylephrine HCL 5mg, packaged in 12 coated caplets daytime formula and 12 coated caplets nighttime formula. Distributed by: Novartis Consumer Health, Inc., Parsippany, NJ. 07054-0622, NDC 0067-2084-24.	Failed Impurities/Degradation:Specifications:Unknown degradant found during stability testing.	Novartis Consumer Health / 38,856/24-caplet package	Class III	Terminated
D-739-2014	05-15-2013	Maximum Strength Comtrex Nighttime Cold & Cough, Acetaminophen 325mg ,Chlorpheniramine Maleate 2mg, Dextromethorphan HBR 10mg,Phenylephrine HCL 5mg, packaged in 24 coated caplets nighttime formula *includes antihistamine, Distributed by: Novartis Consumer Health, Inc., Parsippany, NJ 075054-0622, NDC 0067-2081-24.	Failed Impurities/Degradation:Specifications:Unknown degradant found during stability testing.	Novartis Consumer Health / 32,256/24-caplet packages	Class III	Terminated
D-743-2014	05-15-2013	Theraflu Nighttime Warming Relief Nighttime Multi-Symptom Cold, Acetaminophen 325mg , Chlorpheniramine Maleate 2mg , Dextromethorphan HBr 10mg , Phenylephrine HCL 5mg, a) 8 coated caplets (NDC 0067-6437-08) b) 24 coated caplets (NDC 0067-6438-24). Distributed by: Novartis Consumer Health, Inc., Parsippany, NJ. 07054-0622.	Failed Impurities/Degradation:Specifications:Unknown degradant found during stability testing.	Novartis Consumer Health / 3,768/8-caplet packages and 300,580/24-caplet packages	Class III	Terminated
D-742-2014	05-15-2013	Theraflu Warming Relief, Multi-Symptom Cold, Acetaminophen 325mg, Dextromethorphan HBr 10mg, Phenylephrine HCL 5mg, packaged in a) 8 coated caplets (NDC 0067-6438-08) b) 24 coated caplets (NDC 0067-6438-24), Distributed by: Novartis Consumer Health, Inc., Parsippany, NJ. 07054-0622.	Failed Impurities/Degradation:Specifications:Unknown degradant found during stability testing	Novartis Consumer Health / 98,024/8-caplet packages and 557,548/24-caplet packages	Class III	Terminated
D-1067-2014	05-15-2013	HEALTH & BEYOND DR. LARRY'S Tranquility DIETARY SUPPLEMENT 30 Capsules Manufactured for: Health & Beyond 7050 W Palmetto Pk Rd Boca Raton, FL 33433.	Marketed Without an Approved NDA/ANDA; product found to contain Doxepin (an antidepressant) and Chlorpromazine (an antipsychotic)	Health & Beyond / 46 bottles	Class II	Terminated
D-744-2014	05-15-2013	Excedrin, Sinus Headache, Acetaminophen 325mg, Phenylephrine HCL 5mg , 2 caplets. Distributed by: Novartis Consumer Health, Inc., Parsippany, NJ. 07054-0622, NDC 0067-2062-02.	Failed Impurities/Degradation:Specifications:Unknown degradant found during stability testing	Novartis Consumer Health / 2,978,000/2-caplet packages	Class III	Terminated
D-741-2014	05-15-2013	Maximum Strength Comtrex ,Severe Cold & Sinus Acetaminophen 325mg, Chlorpheniramine Maleate 2mg, Phenylephrine HCL 5mg, packaged in 12 coated caplets daytime formula and 12 coated caplets nighttime formula. Novartis, distributed by: Novartis Consumer Health, Inc., Parsippany, NJ. 07054-0622, NDC 0067-2081-24	Failed Impurities/Degradation:Specifications:Unknown degradant found during stability testing.	Novartis Consumer Health / 167,712/24-caplet packages	Class III	Terminated
D-738-2014	05-15-2013	Maximum Strength Comtrex Day/Night Cold & Cough, Acetaminophen 325mg, Chlorpheniramine Maleate 2mg, Dextromethorphan HBR 10mg, Phenylephrine HCL 5mg, packaged in 16 coated caplets daytime formula and 16 coated caplets nighttime formula *includes antihistamine Distributed by: Novartis Consumer Health, Inc., Parsippany, NJ 075054-0622, NDC 0067-2082-32.	Failed Impurities/Degradation:Specifications:Unknown degradant found during stability testing.	Novartis Consumer Health / 104,328/32-caplet packages	Class III	Terminated
D-0252-2015	05-13-2013	Trace Mineral-5 MDV, supplied in 10 mL vials, Each ML contains: 1 mg Zinc (as sulfate), 0.4 mg Copper (as sulfate), 0.1 mg Manganese (as sulfate), 4 mcg Chromium (as chloride), 20 mcg Selenium (as sodium), 0.9% Benzyl alcohol in water for injection, Rx Only, Compounded Medication, ABRAMS ROYAL Compounding Pharmacy, Dallas, TX	Non-Sterility; contract laboratory identified Staphylococcus warneri in the product	Abrams Royal Pharmacy / 21 vials	Class I	Terminated
D-838-2013	05-13-2013	Warfarin Sodium Tablets, USP 2 mg, Rx Only, 1000 Tablets per bottle, Manufactured by: Cadila Healthcare Ltd Ahmedabad, India, Distributed by: Zydus Pharmaceuticals USA Inc., Pennington, NJ 08534, NDC 68382-053-10	Failed Tablet/Capsule Specifications: A product complaint was received from a pharmacist who discovered that 3 tablets in a 1000-count bottle were oversized.	Zydus Pharmaceuticals USA Inc / 960 Bottles	Class I	Terminated
D-691-2013	05-13-2013	Nicardipine Hydrochloride Injection 25 mg/10 mL (2.5 mg/mL), 10 mL single-use vials, Rx Only, Mfd. by Exela Pharma Sciences, LLC, Lenoir, NC, Dist. by: West-ward Pharmaceutical Corp., Eatontown, NJ --- NDC 0143-9689-10 Package NDCs: 0143-9689-01; 0143-9689-10; 0143-9633-01; 0143-9633-10; 0143-9634-01; 0143-9634-10	Failed Impurity/Degradation Specifications; out of specification value for impurity Nitrophenylpuridine Derivative (NPP-D)	West-ward Pharmaceutical Corp. / Lot PLNJ1201 -16,880 vials ; Lot PLNJ1202 - 16,960 vials	Class III	Terminated
D-835-2013	05-10-2013	Piperacillin and Tazobactam for Injection, USP, 40.5 grams per Pharmacy Bulk Package vial, Rx only, Mfg. by: Hospira Healthcare India Pvt. Ltd., Irungattukottai - 602 105, India; Mfg. for: Apotex Corp., Weston, FL 33326, NDC 60505-0773-0	Crystallization: Potential to exhibit precipitation/crystallization in IV bag or IV line upon reconstitution.	Apotex Corp. / 52,398 vials	Class I	Terminated
D-1055-2014	05-08-2013	Dicopanol FusePaq Kit for Oral Suspension, 5mg/ML	Microbial Contamination of Non-Sterile Products: Fusion Pharmaceuticals is recalling the Dicopanol FusePaq Kit due to Total Yeasts and Molds Count above USP limits.	Fusion Pharmaceuticals, LLC / 1,200 kits	Class II	Terminated
D-610-2013	05-07-2013	Derma-Smoothe/FS (fluocinolone acetonide) Topical Oil (SCALP OIL), 0.01 %, 118.28 mL (4 Fl. oz.) bottle, Rx only, Manufactured and Distributed by: Hill Dermaceuticals, Inc. SANFORD, FLORIDA 32773; NDC 28105-149-04.	Subpotent Drug: the active ingredient, fluocinolone acetonide, was found to be subpotent during the firm's routine testing.	Hill Dermaceuticals, Inc. / 8,808 bottles	Class III	Terminated
D-833-2013	05-06-2013	Lightning ROD capsules, 500 mg/capsule, packaged in 3-count bottles (UPC 6 89076 20257 2).	Marketed Without An Approved NDA/ANDA: Lightning Rod capsules are being recalled because FDA analysis found it to contain an undeclared analogue of sildenafil. Sildenafil is the active ingredient in an FDA-approved product indicated for the treatment of male erectile dysfunction (ED), making this product an unapproved new drug.	Chang Kwung Products / 3,720 capsules total	Class I	Terminated
D-834-2013	05-06-2013	Lightning ROD capsules, 550 mg/capsule, packaged in 12-count bottles (UPC 6 89076 20297 8).	Marketed Without An Approved NDA/ANDA: Lightning Rod capsules are being recalled because FDA analysis found it to contain an undeclared analogue of sildenafil. Sildenafil is the active ingredient in an FDA-approved product indicated for the treatment of male erectile dysfunction (ED), making this product an unapproved new drug.	Chang Kwung Products / 3,720 capsules total	Class I	Terminated
D-620-2013	05-03-2013	Pure-Aid Allergy Relief, Diphenhydramine HCL Caplets, 25 mg, 20 caplets, Exclusively distributed by: Kareway Products Inc., Compton, CA --- UPC 8 56023 00158 2	Labeling: Not Elsewhere Classified; foil label on immediate blister pack indicates active ingredient as Chlorpheniramine rather than Diphenhydramine	Kareway Product Inc / 24,048 cartons	Class II	Terminated
D-554-2013	05-02-2013	Dexpanthenol 200 mg/mL Injectable, 100 mL vial, compounded by The Compounding Shop, St. Petersburg, FL	Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes	THE COMPOUNDING SHOP, INC. / 2 vials of 100mL	Class II	Terminated
D-568-2013	05-02-2013	Morphine Sulfate 25 mg/mL Injectable, 40 mL vial, compounded by The Compounding Shop, St. Petersburg, FL	Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes	THE COMPOUNDING SHOP, INC. / 1 vial of 40mL	Class II	Terminated
D-570-2013	05-02-2013	Praziquantel 56.8 mg, 50 mL vial, compounded by The Compounding Shop, St. Petersburg, FL	Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes	THE COMPOUNDING SHOP, INC. / 5 vials of 50mL	Class II	Terminated
D-552-2013	05-02-2013	Baclofen/Bupivacaine 2,000 mcg/20 mg/mL Injectable, 45 mL vial, Compounded by The Compounding Shop, St. Petersburg, FL	Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes	THE COMPOUNDING SHOP, INC. / 3 vials of 45mL	Class II	Terminated
D-558-2013	05-02-2013	Glutathione 200 mg/mL Injectable, 50 mL vials, compounded by The Compounding Shop, St. Petersburg, FL	Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes	THE COMPOUNDING SHOP, INC. / 7 vials of 50mL each	Class II	Terminated