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FDA Recalls
›Drug Recalls

FDA Drug Recalls

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

Classification

All Class I Class II Class III

Status

All Ongoing Completed Terminated

Date

All time Past 30 days Past 12 months

Showing 11581–11600 of 17,816 recalls

Class IITerminated

aloe SPORT liniment TOPICAL ANALGESIC 8 fl oz. tube, ALOE VERA Liniment Topical Analgesic 8 fl oz. bottle, Manufactured by Coats International, Inc., the ALOE SOURCE SPORT Sport Thermogenic Eucalyptus Cream 1 fl oz. plastic bottle, Dallas, TX 75243, NDC 58826-704-08, UPC 732295704089

The Aloe Source

CGMP Deviations

May 11, 2016 · DrugView details →

Class IITerminated

VERMOX Tablets 100 mg; 6-count box, UPC 7501109900619

Profarma Distributors LLC

CGMP Deviations

May 11, 2016 · DrugView details →

Class IITerminated

tabcin NOCHE; Capsules,12-count box, UPC 501008485033

Profarma Distributors LLC

CGMP Deviations

May 11, 2016 · DrugView details →

Class IITerminated

Tazorac (tazarotene) Gel 0.05%, Rx only, packaged in a) 30g (NDC 0023-8335-03) and b) 100g (NDC 0023-8335-10) tubes, Allergan Inc, Irvine, CA 92612

Allergan Sales, LLC

Failed Content Uniformity Specifications.

May 10, 2016 · DrugView details →

Class IITerminated

Coppertone SUNSCREEN LOTION, CLEARLY SHEER, BROAD SPECTRUM SPF 50, 5 FL OZ (147mL), OTC, Dist by: Bayer HealthCare LLC, Whippany, NJ 07981 --- NDC 11523-7391-1, UPC 00041100005762

Bayer Health Care LLC

Labeling; Product Contains Undeclared API (Oxybenzone)

May 10, 2016 · DrugView details →

Class IITerminated

Tazorac (tazarotene) Gel 0.05%, 15 x 3.5g, sample packs, Allergan Inc, Irvine, CA 92612. UPC 300238335159

Allergan Sales, LLC

Failed Content Uniformity Specifications.

May 10, 2016 · DrugView details →

Class IITerminated

Bromocriptine Mesylate Capsules USP, 5 mg, 30-count bottles, Rx only, Manufactured by: Cadila Healthcare ltd., Ahmedabad, India Distributed by: Zydus Pharmaceuticals USA Inc., Pennington, NJ 08534, NDC 68382-110-06

Zydus Pharmaceuticals USA Inc

Failed impurities/degradation specifications: Out of specification results noticed in related substance test during analysis of 24 months long term (25 degree Celsius /65% RH) stability samples of two batches.

May 9, 2016 · DrugView details →

Class IITerminated

Vancomycin Hydrochloride for Injection, USP, 10 g, 100 mL vial, Rx only, Hospira, Lake Forest, IL, NDC 0409-6510-01

Hospira Inc.

Presence of Particulate Matter: Cardboard

May 6, 2016 · DrugView details →

Class IITerminated

2 mcg/mL Fentanyl Citrate and 0.16% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride, 100 mL in 150 mL Baxter Intravia Bag, Service Code 2K8102, Rx Only, Compounded by PharMEDium Services, LLC, Memphis, TN 36141, NDC 61553-102-48

Pharmedium Services, LLC

Presence of Particulate Matter: API contaminated with glass particulate was used to produce sterile injectable drugs.

May 5, 2016 · DrugView details →

Class IITerminated

10 mcg/mL HYDROmorphone HCl and 0.075% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride, 250 mL in 250 mL Hospira LifeCare Bag, Service Code 2H8480, Rx Only, Compounded by PharMEDium Services, LLC, Memphis, TN 36141, NDC 61553-480-50

Pharmedium Services, LLC

Presence of Particulate Matter: API contaminated with glass particulate was used to produce sterile injectable drugs.

May 5, 2016 · DrugView details →

Class IITerminated

2 mcg/mL Fentanyl Citrate and 0.125% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride; Service Code 2H8125 , NDC 61553-125-52 , 100 ml in 100 ml Hospira LifeCare Bag ; Service Code 2H8204 , NDC 61553-204-54 , 200 ml in 250 ml Hospira LifeCare Bag ; Service Code 2H8205 , NDC 61553-205-50 , 250 ml in 250 ml Hospira LifeCare Bag ; Service Code 2K8104 , NDC 61553-104-03 , 500 ml in 500 ml Baxter Intravia Bag ; Service Code 2K8124 , NDC 61553-124-48 , 100 ml in 150 ml Baxter Intravia Bag ; Service Code 2K8204 , NDC 61553-204-37 , 200 ml in 250 ml Baxter Intravia Bag ; Service Code 2K8205 , NDC 61553-205-02 , 250 ml in 250 ml Baxter Intravia Bag ; Service Code 2K8443 , NDC 61553-443-47 , 150 ml in 150 ml Baxter Intravia Bag ; Service Code 2K8491 , NDC 61553-491-30 , 125 ml in 150 ml Baxter Intravia Bag ; Service Code 2K9491 , NDC 61553-491-96 , 100 ml in 150 ml Baxter Intravia Bag ; Service Code 2K9802 , NDC 61553-802-96 , 100 ml in 150 ml Baxter Intravia Bag ; Service Code 4J8205 , NDC 61553-205-97 , 250 ml in 250 ml Baxter Intravia Bag ; Rx Only, Compounded by PharMEDium Services, LLC, Memphis, TN 36141

Pharmedium Services, LLC

Presence of Particulate Matter: API contaminated with glass particulate was used to produce sterile injectable drugs.

May 5, 2016 · DrugView details →

Class IITerminated

0.4 mcg/mL Sufentanil Citrate and 0.1% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride, 250 mL in 250 mL Hospira LifeCare Bag, Service Code 2H8577, Rx Only, Compounded by PharMEDium Services, LLC, Memphis, TN 36141, NDC 61553-577-50

Pharmedium Services, LLC

Presence of Particulate Matter: API contaminated with glass particulate was used to produce sterile injectable drugs.

May 5, 2016 · DrugView details →

Class IITerminated

0.5 mcg/mL Sufentanil Citrate and 0.1% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride, 100 mL in 100 mL Yellow Smiths Medical Cassette, Service Code 2T8317, Rx Only, Compounded by PharMEDium Services, LLC, Memphis, TN 36141, NDC 61553-317-52

Pharmedium Services, LLC

Presence of Particulate Matter: API contaminated with glass particulate was used to produce sterile injectable drugs.

May 5, 2016 · DrugView details →

Class IITerminated

1 mcg/mL Sufentanil Citrate and 0.1% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride, 100 ml in 100 ml Hospira LifeCare Bag, Service Code 2H8919, Rx Only, Compounded by PharMEDium Services, LLC, Memphis, TN 36141, NDC 61553-0919-52

Pharmedium Services, LLC

Presence of Particulate Matter: API contaminated with glass particulate was used to produce sterile injectable drugs.

May 5, 2016 · DrugView details →

Class IITerminated

2 mcg/mL Fentanyl Citrate and 0.2% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride, 250 mL in 250 mL Baxter Intravia Bag, Service Code 2K8108, Rx Only, Compounded by PharMEDium Services, LLC, Memphis, TN 36141, NDC 61553-108-02

Pharmedium Services, LLC

Presence of Particulate Matter: API contaminated with glass particulate was used to produce sterile injectable drugs.

May 5, 2016 · DrugView details →

Class IITerminated

6.66 mcg/mL Fentanyl Citrate and 0.22% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride, 15 mL in 20 mL BD Syringe, Service Code 2T6156, Rx Only, Compounded by PharMEDium Services, LLC, Memphis, TN 36141, NDC 61553-156-86

Pharmedium Services, LLC

Presence of Particulate Matter: API contaminated with glass particulate was used to produce sterile injectable drugs.

May 5, 2016 · DrugView details →

Class IITerminated

5 mcg/mL Fentanyl Citrate and 0.04% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride, 100 mL in 100 mL Yellow Smiths Medical Cassette, flow stop free-flow protection, Service Code 2K8809, Rx Only, Compounded by PharMEDium Services, LLC, Memphis, TN 36141, NDC 61553-809-48

Pharmedium Services, LLC

Presence of Particulate Matter: API contaminated with glass particulate was used to produce sterile injectable drugs.

May 5, 2016 · DrugView details →

Class IITerminated

10 mcg/mL Fentanyl Citrate and 0.0625% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride, 250 ml in 250 ml Hospira LifeCare Bag ,Rx Only, Compounded by PharMEDium Services, LLC, Memphis, TN 36141, NDC 61553-143-50

Pharmedium Services, LLC

Presence of Particulate Matter: API contaminated with glass particulate was used to produce sterile injectable drugs.

May 5, 2016 · DrugView details →

Class IITerminated

0.05 mg/mL Morphine Sulfate and 0.0625% Bupivacaine HCI (Preservative Free) in 0.9% Sodium Chloride, 250 mL Hospira LifeCare bag, Rx Only, Compounded by PharMEDium Services, LLC, Memphis, TN 36141, NDC 61553-995-54 ,

Pharmedium Services, LLC

Presence of Particulate Matter: API contaminated with glass particulate was used to produce sterile injectable drugs.

May 5, 2016 · DrugView details →

Class IITerminated

5 mcg/mL HYDROmorphone HCl and 0.125% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride, 50 mL in 60 mL BD Syringe, Service Code 2T6197, Rx Only, Compounded by PharMEDium Services, LLC, Memphis, TN 36141, NDC 61553-197-20

Pharmedium Services, LLC

Presence of Particulate Matter: API contaminated with glass particulate was used to produce sterile injectable drugs.

May 5, 2016 · DrugView details →

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