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  1. FDA Recalls
  2. ›Drug Recalls

FDA Drug Recalls

Recalls of prescription drugs, over-the-counter medications, and compounded pharmaceuticals.

Classification
AllClass IClass IIClass III
Status
AllOngoingCompletedTerminated
Date
All timePast 30 daysPast 12 months

Showing 9321–9340 of 17,793 recalls

Class IITerminated

My Way (Levonorgestrel) Tablets TWO PACK, 1.5 mg each, packaged as 2 Treatments (Two 1.5mg Levonorgestrel Tablets) per carton, GAVIS Pharmaceuticals, A Lupin Group Company; Mfg. for Lupin Pharmaceuticals, Inc., Baltimore, MD 21202, UPC 3 43386-622-31 3.

Lupin Pharmaceuticals Inc.

Marketed Without an Approved NDA/ANDA: 2-pack configuration did not receive appropriate regulatory approval prior to release.

May 17, 2018 · DrugView details →
Class IITerminated

My Way (levonorgestrel) Tablets TWO PACK, 1.5 mg each, packaged as 2 Treatments (Two 1.5mg Levonorgestrel Tablets) per carton, Manufactured for: Lupin Pharmaceuticals, Inc., Baltimore, MD 21202; Manufactured by: Lupin Limited, Pithampur (M.P.) - 454 775, INDIA, UPC 3 68180 85212 4.

Lupin Pharmaceuticals Inc.

Marketed Without an Approved NDA/ANDA: 2-pack configuration did not receive appropriate regulatory approval prior to release.

May 17, 2018 · Drug
View details →
Class IITerminated

Cefazolin 2 Gm/20 mL 20 ml. Rx Only. Packaged in 20 mL syringes. Compounded Guardian Pharmacy Services, 7920 Elmbrook Dr. Ste. 108C Dallas TX 75247

Guardian Pharmacy Services

Lack of sterility assurance.

May 17, 2018 · DrugView details →
Class IITerminated

Glycopyrrolate 0.2 mg/mL 2ml. Rx Only. Packaged in 2 mL syringes. Compounded Guardian Pharmacy Services, 7920 Elmbrook Dr. Ste. 108C Dallas TX 75247

Guardian Pharmacy Services

Lack of sterility assurance.

May 17, 2018 · DrugView details →
Class ITerminated

POSEIDON Xtreme PLATINUM 4500,1000mg, packaged in single packs sold in 24-count boxes, Distributed by: Poseidon Distribution Atlanta, GA, UPC 638632428857

Shoreside Enterprises Inc.

Marketed Without An Approved NDA/ANDA: FDA analysis found products to contain undeclared sildenafil and tadalafil. The presence of sildenafil and tadalafil makes these products an unapproved drug for which safety and efficacy have not been established and, therefore, subject to recall.

May 17, 2018 · DrugView details →
Class IITerminated

Ropivacaine HCl 2 mg/mL 400 mL. Rx Only. Packaged in a ON-Q Pump. Compounded Guardian Pharmacy Services, 7920 Elmbrook Dr. Ste. 108C Dallas TX 75247

Guardian Pharmacy Services

Lack of sterility assurance.

May 17, 2018 · DrugView details →
Class IITerminated

B-Complex Rx only. packaged in a) 100 mL bag b) 100 ml MDV vial. Compounded Guardian Pharmacy Services, 7920 Elmbrook Dr. Ste. 108C Dallas TX 75247

Guardian Pharmacy Services

Lack of sterility assurance.

May 17, 2018 · DrugView details →
Class IITerminated

Ropivacaine HCl 2 mg/mL 550 mL. Rx Only. Packaged in a ON-Q Pump. Compounded Guardian Pharmacy Services, 7920 Elmbrook Dr. Ste. 108C Dallas TX 75247

Guardian Pharmacy Services

Lack of sterility assurance.

May 17, 2018 · DrugView details →
Class IITerminated

Ropivacaine HCl 2 mg/mL 750 mL. Rx Only. Packaged in a ON-Q Pump. Compounded Guardian Pharmacy Services, 7920 Elmbrook Dr. Ste. 108C Dallas TX 75247

Guardian Pharmacy Services

Lack of sterility assurance.

May 17, 2018 · DrugView details →
Class IITerminated

Medroxyprogesterone 150 mg/mL 5ml. Rx Only. Packaged in 5 mL vials. Compounded Guardian Pharmacy Services, 7920 Elmbrook Dr. Ste. 108C Dallas TX 75247

Guardian Pharmacy Services

Lack of sterility assurance.

May 17, 2018 · DrugView details →
Class IITerminated

Fentanyl Citrate 50 mcg/mL 2ml. Rx Only. Packaged in 2 mL syringes. Compounded Guardian Pharmacy Services, 7920 Elmbrook Dr. Ste. 108C Dallas TX 75247

Guardian Pharmacy Services

Lack of sterility assurance.

May 17, 2018 · DrugView details →
Class IITerminated

Methylcobalamin 1000 mcg/mL 100 mL. RX Only. Packaged in 100ml MDV vials. Compounded Guardian Pharmacy Services, 7920 Elmbrook Dr. Ste. 108C Dallas TX 75247

Guardian Pharmacy Services

Lack of sterility assurance.

May 17, 2018 · DrugView details →
Class IITerminated

Hyaluronidase 150 units/mL 1ml. Rx Only. Packaged in 1 mL vials. Compounded Guardian Pharmacy Services, 7920 Elmbrook Dr. Ste. 108C Dallas TX 75247

Guardian Pharmacy Services

Lack of sterility assurance.

May 17, 2018 · DrugView details →
Class IITerminated

Magnesium Sulfate 200 mg/mL, 100ml. Rx. Only. Packaged in 100 mL MDV vials. Compounded Guardian Pharmacy Services, 7920 Elmbrook Dr. Ste. 108C Dallas TX 75247

Guardian Pharmacy Services

Lack of sterility assurance.

May 17, 2018 · DrugView details →
Class IITerminated

EDTA Disodium 30 mg/mL PF. Rx Only. Packaged in 1 mL pre filled syringe. Compounded Guardian Pharmacy Services, 7920 Elmbrook Dr. Ste. 108C Dallas TX 75247

Guardian Pharmacy Services

Lack of sterility assurance.

May 17, 2018 · DrugView details →
Class IITerminated

Lidocaine 3% 10 ml. Rx Only. Packaged in 10 mL syringes. Compounded Guardian Pharmacy Services, 7920 Elmbrook Dr. Ste. 108C Dallas TX 75247

Guardian Pharmacy Services

Lack of sterility assurance.

May 17, 2018 · DrugView details →
Class IITerminated

screamin' hot (capsaicin) Pain Relieving Gel, 0.03%, packaged in a) 2 OZ (57g) tubes, UPC 7 50263 80072 4; b) 5 oz. (141g) tubes, UPC 7 50263 80007 6; and c) 16 oz. (454g) bottles, UPC 7 50263 80076 2; MFD FOR: Toast Products, 400 Sproul Street, Pittsburgh, PA 15136; NDC 52099-8005.

Ideaz Llc

CGMP Deviations: Products manufactured with an ingredient that exceed the benzene levels allowed in drug products.

May 16, 2018 · DrugView details →
Class IITerminated

screamin' menthol (menthol) Pain Relieving Gel, 4%, packaged in a) 2 OZ (57g) tubes, UPC 7 50263 80062 5; b) 5 oz. (141g) tubes, UPC 7 50263 80006 9; and c) 16 oz. (454g) bottles, UPC 7 50263 80066 3; MFD FOR: Toast Products, 400 Sproul Street, Pittsburgh, PA 15136; NDC 52099-8010.

Ideaz Llc

CGMP Deviations: Products manufactured with an ingredient that exceed the benzene levels allowed in drug products.

May 16, 2018 · DrugView details →
Class IITerminated

Option Systems Antibacterial Foaming Hand Wash with .3% PCMX, 1000 mL pouches, Inopak, LTD, Ringwood, NJ

Inopak Ltd

Microbial contamination of NonSterile Product; FDA analysis returned out of specification results for total aerobic microbial counts

May 16, 2018 · DrugView details →
Class IITerminated

Argentum Elixir Colloidal Silver, 50 PPM Homeopathic Infection Fighter, 8 fl oz. amber PET bottle with white sprayer. MBi nutraceuticals Lindon UT, 84042. Bar COde: 3 58301 18114 1

MBi Distributing Inc. dba MBi Nutraceuticals

Lack of Processing Controls: Firm is voluntarily recalling all lots of homeopathic Teething Drops, Nausea Drops, Intestinal Colic Drops, Stomach Calm, Expectorant Cough Syrup, Silver-Zinc Throat Spray, and Argentum Elixir, within expiry, due to lack of adequate controls during manufacturing.

May 15, 2018 · DrugView details →
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