July 10, 2019DrugsFDA
PharMEDium Services, LLC recalls Hydromorphone HCl in 0.9% sodium chloride, 0.5mg per mL, 1 mL in 3mL BD Syringe, PharMEDium 913 N Davis Ave Cleveland,
Hazard: Incorrect Product Formulation; Firm's customer resource center (CRC) statement indicates that the product is sulfite free, however the product is produced with a raw material that contains sulfite
July 10, 2019DrugsFDA
InvaGen Pharmaceuticals, Inc. recalls Testosterone Topical Solution 30mg of testosterone per pump actuation * each actuation delivers 1.5 mL of solution Total
Hazard: Defective Container; actuator may improperly function and affect dose delivery.
July 10, 2019DrugsFDA
Amneal Pharmaceuticals, Inc. recalls Esterified Estrogens & Methyltestosterone Tablets, USP 1.25 mg/2.5 mg, 100-count bottles, Rx Only, Manufactured by: Amm
Hazard: Subpotent Drug: Out of specification assay result in Esterified Estrogen and Methyltestosterone tablets.
July 10, 2019DrugsFDA
Amneal Pharmaceuticals, Inc. recalls Esterified Estrogens & Methyltestosterone Tablets, USP 0.625 mg/1.25 mg, 100-count bottles, Rx Only, Manufactured by: A
Hazard: Subpotent Drug: Out of specification assay result in Esterified Estrogen and Methyltestosterone tablets.
July 3, 2019DrugsFDA
American Health Packaging recalls Pramipexole Dihydrochloride Tablets, 1.0 mg, 30 Tablets (6 tablets per blister card), Rx Only, Distributed by: American
Hazard: GMP Deviations; possible cross contamination of product due to cleaning procedure failure.
July 3, 2019DrugsFDA
American Health Packaging recalls Pramipexole Dihydrochloride Tablets, 0.5 mg, 30 Tablets (6 tablets per blister card), Rx Only, Distributed by: American
Hazard: GMP Deviations; possible cross contamination of product due to cleaning procedure failure.
July 3, 2019DrugsFDA
American Health Packaging recalls Pramipexole Dihydrochloride Tablets, 0.25 mg, 100 Tablets (10 x 10), Rx Only, Packaged and Distributed by: American Hea
Hazard: GMP Deviations; possible cross contamination of product due to cleaning procedure failure.
July 3, 2019DrugsFDA
American Health Packaging recalls Pramipexole Dihydrochloride Tablets, 0.125 mg, 30 Tablets (6 tablets per blister card), Rx Only, Distributed by: Americ
Hazard: GMP Deviations; possible cross contamination of product due to cleaning procedure failure.
July 3, 2019DrugsFDA
H J Harkins Company Inc dba Pharma Pac recalls Diphenhydramine HCL Liquid, 12.5 mg/5 mL, 4 oz bottle, Manufactured by Torrent Pharma, Inc., Levittown, PA 19057, NDC 52
Hazard: Microbial Contamination of Non-sterile Products: Potential product contamination with Burkholderia cepacia (B.cepacia) and Ralstonia pickettii (R. pickettii).
July 3, 2019DrugsFDA
H J Harkins Company Inc dba Pharma Pac recalls Acetaminophen Children's Liquid, 160 mg/5 mL, 4 oz bottle, Manufactured by Torrent Pharma, Inc., Levittown, PA 19057, ND
Hazard: Microbial Contamination of Non-sterile Products: Potential product contamination with Burkholderia cepacia (B.cepacia) and Ralstonia pickettii (R. pickettii).
July 3, 2019DrugsFDA
Premier Pharmacy Labs Inc recalls SUCCINYLcholine Chloride, 200mg/10mL (20mg/mL), 10mL Sterile Single Dose Syringe, Rx only, Premier Pharmacy Labs, 8265 C
Hazard: Lack of Assurance of Sterility: FDA inspection found insufficient environmental controls, potential cross contamination and lack of product specific process validations that can result in a lack of sterility assurance.
July 3, 2019DrugsFDA
Premier Pharmacy Labs Inc recalls SUCCINYLcholine Chloride, 100mg/5mL (20mg/mL), 5mL Sterile Single-Use Syringe, Rx only, Premier Pharmacy Labs, 8265 Comm
Hazard: Lack of Assurance of Sterility: FDA inspection found insufficient environmental controls, potential cross contamination and lack of product specific process validations that can result in a lack of sterility assurance.
July 3, 2019DrugsFDA
Premier Pharmacy Labs Inc recalls Sodium Bicarbonate INJ 8.4%, 50 mEq/50mL (84mg/mL) (1mEq/mL), 50mL Sterile SDV, Rx only, Premier Pharmacy Labs, 8265 Com
Hazard: Lack of Assurance of Sterility: FDA inspection found insufficient environmental controls, potential cross contamination and lack of product specific process validations that can result in a lack of sterility assurance.
July 3, 2019DrugsFDA
Premier Pharmacy Labs Inc recalls Riboflavin 5-Phosphate Sodium Ophthalmic Solution, 19.05mg/3mL (6.35 mg/mL), 3 mL Dropper Bottle, Rx only, Premier Pharm
Hazard: Lack of Assurance of Sterility: FDA inspection found insufficient environmental controls, potential cross contamination and lack of product specific process validations that can result in a lack of sterility assurance.
July 3, 2019DrugsFDA
Premier Pharmacy Labs Inc recalls Phenylephrine HCL PF INJ in 0.9% Sodium Chloride, 1000mcg/10mL (100mgc/mL), *Contains Sulfites*, 10mL Single-Dose Syring
Hazard: Lack of Assurance of Sterility: FDA inspection found insufficient environmental controls, potential cross contamination and lack of product specific process validations that can result in a lack of sterility assurance.
July 3, 2019DrugsFDA
Premier Pharmacy Labs Inc recalls Orphenadrine Citrate Sterile Injectable Solution *Contains Sulfites*, 30mg/mL, 1mL Sterile Single-Use Syringe, Rx only,
Hazard: Lack of Assurance of Sterility: FDA inspection found insufficient environmental controls, potential cross contamination and lack of product specific process validations that can result in a lack of sterility assurance.
July 3, 2019DrugsFDA
Premier Pharmacy Labs Inc recalls Neostigmine Methylsulfate, 5mg/5mL (1mg/mL), 5mL Single Dose Syringe, Rx only, Premier Pharmacy Labs, 8265 Commercial Wa
Hazard: Lack of Assurance of Sterility: FDA inspection found insufficient environmental controls, potential cross contamination and lack of product specific process validations that can result in a lack of sterility assurance.
July 3, 2019DrugsFDA
Premier Pharmacy Labs Inc recalls Naloxone HCL Preserved INJ, 500mg/50mL (10mg/mL), 50mL Sterile MDV, Rx only, Premier Pharmacy Labs, 8265 Commercial Way,
Hazard: Lack of Assurance of Sterility: FDA inspection found insufficient environmental controls, potential cross contamination and lack of product specific process validations that can result in a lack of sterility assurance.
July 3, 2019DrugsFDA
Premier Pharmacy Labs Inc recalls Mitomycin Preservative Free Irrigation, 40mg/10mL (4mg/mL), 10mL SDV, Rx only, Premier Pharmacy Labs, 8265 Commercial Wa
Hazard: Lack of Assurance of Sterility: FDA inspection found insufficient environmental controls, potential cross contamination and lack of product specific process validations that can result in a lack of sterility assurance.
July 3, 2019DrugsFDA
Premier Pharmacy Labs Inc recalls Lidocaine 0.5%/Phenylephrine 0.75% P.F. INJ, 1mL Sterile SDV, Rx only, Premier Pharmacy Labs, 8265 Commercial Way, Weeki
Hazard: Lack of Assurance of Sterility: FDA inspection found insufficient environmental controls, potential cross contamination and lack of product specific process validations that can result in a lack of sterility assurance.
July 3, 2019DrugsFDA
Premier Pharmacy Labs Inc recalls Isoproterenol HCL in D5W, 500mcg/50mL (10mcg/mL), 50mL Sterile Single-Dose Bag, Rx only, Premier Pharmacy Labs, 8265 Com
Hazard: Lack of Assurance of Sterility: FDA inspection found insufficient environmental controls, potential cross contamination and lack of product specific process validations that can result in a lack of sterility assurance.
July 3, 2019DrugsFDA
Premier Pharmacy Labs Inc recalls Isoproterenol HCL in D5W (Non Sterile to Sterile), 200mcg/50mL (4mcg/mL), 50mL Sterile Single-Dose Bag, Rx only, Premier
Hazard: Lack of Assurance of Sterility: FDA inspection found insufficient environmental controls, potential cross contamination and lack of product specific process validations that can result in a lack of sterility assurance.
July 3, 2019DrugsFDA
Premier Pharmacy Labs Inc recalls Isoproterenol HCL in D5W (Sterile to Sterile), 200mcg/50mL (4mcg/mL), 50mL Sterile Single-Dose Bag, Rx only, Premier Pha
Hazard: Lack of Assurance of Sterility: FDA inspection found insufficient environmental controls, potential cross contamination and lack of product specific process validations that can result in a lack of sterility assurance.
July 3, 2019DrugsFDA
Premier Pharmacy Labs Inc recalls Droperidol Injectable Sterile Solution, 0.625mg/mL, 1mL in a 3mL Sterile Single-Use Syringe, Rx only, Premier Pharmacy L
Hazard: Lack of Assurance of Sterility: FDA inspection found insufficient environmental controls, potential cross contamination and lack of product specific process validations that can result in a lack of sterility assurance.
July 3, 2019DrugsFDA
Premier Pharmacy Labs Inc recalls Dexamethasone Sodium Phosphate Preservative Free Sterile Solution for INJ, 24mg/mL, 1mL Sterile Single-Use Syringe, Rx o
Hazard: Lack of Assurance of Sterility: FDA inspection found insufficient environmental controls, potential cross contamination and lack of product specific process validations that can result in a lack of sterility assurance.
July 3, 2019DrugsFDA
Premier Pharmacy Labs Inc recalls ChlorproMAZINE HCL INJ, 25mg/mL, *Contains Sulfites*, 1mL in a 5mL Sterile SDV, Rx only, Premier Pharmacy Labs, 8265 Com
Hazard: Lack of Assurance of Sterility: FDA inspection found insufficient environmental controls, potential cross contamination and lack of product specific process validations that can result in a lack of sterility assurance.
July 3, 2019DrugsFDA
Premier Pharmacy Labs Inc recalls Brilliant Blue Ophthalmic PF INJ, 0.5mg/mL (0.05%), 1 mL SDV, Rx only, Premier Pharmacy Labs, 8265 Commercial Way, Weeki
Hazard: Lack of Assurance of Sterility: FDA inspection found insufficient environmental controls, potential cross contamination and lack of product specific process validations that can result in a lack of sterility assurance.
July 3, 2019DrugsFDA
Premier Pharmacy Labs Inc recalls Atropine Sulfate PF INJ, 0.8 mg/2 mL (0.4 mg/mL), 2mL Single Dose Syringe, Rx only, Premier Pharmacy Labs, 8265 Commerci
Hazard: Lack of Assurance of Sterility: FDA inspection found insufficient environmental controls, potential cross contamination and lack of product specific process validations that can result in a lack of sterility assurance.
June 26, 2019DrugsFDA
Zydus Pharmaceuticals USA Inc recalls MethylPREDNISolone Tablets, USP 8 mg, 25 tablets, Rx Only, Manufactured by: Cadila Healthcare Ltd. Ahmedabad, India NDC
Hazard: CGMP Deviations: Cross Contamination with other products due to CGMP cleaning failure.
June 26, 2019DrugsFDA
Zydus Pharmaceuticals USA Inc recalls Pramipexole Dihydrochloride Tablets 1.5 mg 90-count bottle, Rx only Manufactured by: Cadila Healthcare Ltd. Ahmedabad, I
Hazard: CGMP Deviations: Cross Contamination with other products due to CGMP cleaning failure.