Drug and pharmaceutical recalls
17728 federal recalls on file. Federal recalls for prescription drugs, OTC medications, supplements, and pharmaceuticals. Sourced from the FDA and translated into plain English.
- 2019-01-16FDA-DrugLupin Pharmaceuticals Inc.Class IICefdinir for Oral Suspension USP, 125mg/5mL, packaged in a) 60mL (NDC 68180-722-20), b)100mL (NDC 68180-722-10), Rx Only, Manufactured for: Lupin Pharmaceuticals Inc. Baltimore, MD 21202; Manufactured by: Lupin Limited Mandideep 462 046 INDIA
CGMP Deviations: Product complaints received indicating reconstituted suspension was observed to be thick.
- 2019-01-16FDA-DrugPharMEDium Services, LLC.Class II0.9% Buffered Lidocaine HCl (buffered in 8.4% Sodium Bicarbonate) a.) 1 mL in 3 mL BD Syringe, 10 per carton, b.) 0.9% Buffered Lidocaine HCl (buffered in 8.4% Sodium Bicarbonate) 5 mL in 5 mL BD Syringe, 10 per carton Rx Only, Compounded by PharMEDium Services, LLC, Sugar Land, TX 77478.
Subpotent
- 2019-01-16FDA-DrugSun Pharmaceutical Industries, Inc.Class IVecuronium Bromide for Injection 20 mg* *1mg/mL when reconstituted to 20 mL Lyophilized, 10 x 20 mg vials, Rx Only, Manufactured by: Sun Pharmaceutical Industries Ltd. Halol-Baroda Highway Halol-389 350, Gujarat, India. Distributed by: Sun Pharmaceutical Industries, Inc. Cranbury, NJ 08512 NDC: 47335-932-40 [vial] 47335-932-44 [carton]
Presence of Particulate Matter: Foreign matter identified as glass detected in Vecuronium Bromide for Injection.
- 2019-01-16FDA-DrugSun Pharmaceutical Industries, Inc.Class IVecuronium Bromide for Injection 10 mg*, *1mg/mL when reconstituted to 10 mL Lyophilized, 10 x 10 mg vials, Rx only, Manufactured by: Sun Pharmaceutical Industries Ltd. Halol-Baroda Highway Halol-389 350, Gujarat, India. Distributed by: Sun Pharmaceutical Industries, Inc. Cranbury, NJ 08512 NDC 47335-931-40 [vial] NDC 47335-931-44 [carton]
Presence of Particulate Matter: Foreign matter identified as glass detected in Vecuronium Bromide for Injection.
- 2019-01-16FDA-DrugLupin Pharmaceuticals Inc.Class ICeftriaxone for Injection USP, 2 g, packaged in 10 Single Use Vials (NDC 68180-644-01) per box, Rx only, Manufactured for: Lupin Pharmaceuticals, Inc., 111 South Calvert Street, Baltimore, Maryland 21202; Manufactured by: Lupin Limited, Mandideep 462 046 INDIA, NDC 68180-644-10.
Presence of Particulate Matter: Product complaints received of grey flecks, identified as shredded rubber particulate matter from the stopper observed in reconstituted vials.
- 2019-01-16FDA-DrugLupin Pharmaceuticals Inc.Class ICeftriaxone for Injection USP, 1 g, packaged in a) one Single Use Vial (NDC 68180-633-01) and b) 10 Single Use Vials per box (NDC 68180-633-10); Rx only, Manufactured for: Lupin Pharmaceuticals, Inc., 111 South Calvert Street, Baltimore, Maryland 21202; Manufactured by: Lupin Limited, Mandideep 462 046 INDIA.
Presence of Particulate Matter: Product complaints received of grey flecks, identified as shredded rubber particulate matter from the stopper observed in reconstituted vials.
- 2019-01-16FDA-DrugLupin Pharmaceuticals Inc.Class ICeftriaxone for Injection USP, 500 mg, packaged in a) one Single Use Vial (NDC 68180-622-01) and b) 10 Single Use Vials per box (NDC 68180-622-10); Rx only, Manufactured for: Lupin Pharmaceuticals, Inc., 111 South Calvert Street, Baltimore, Maryland 21202; Manufactured by: Lupin Limited, Mandideep 462 046 INDIA.
Presence of Particulate Matter: Product complaints received of grey flecks, identified as shredded rubber particulate matter from the stopper observed in reconstituted vials.
- 2019-01-16FDA-DrugLupin Pharmaceuticals Inc.Class ICeftriaxone for Injection USP, 250 mg, packaged in a) one Single Use Vial (NDC 68180-611-01) and b) 10 Single Use Vials per box (NDC 68180-611-10); Rx only, Manufactured for: Lupin Pharmaceuticals, Inc., 111 South Calvert Street, Baltimore, Maryland 21202; Manufactured by: Lupin Limited, Mandideep 462 046 INDIA.
Presence of Particulate Matter: Product complaints received of grey flecks, identified as shredded rubber particulate matter from the stopper observed in reconstituted vials.
- 2019-01-16FDA-DrugHeritage Pharmaceuticals, Inc.Class IICidofovir Injection 375mg/5mL (75mg/mL) vial injection. 5 mL vials, Rx only, Mfd by: Emcure Pharmaceuticals Ltd., Hinjawadi, Pune, India Mfg. for : Heritage Pharmaceuticals Inc. NDC 23155-0216-31
Lack of Assurance of Sterility: complaints received about dried powder on the outside of bottle
- 2019-01-16FDA-DrugBaxter Healthcare CorporationClass IIDianeal Low Calcium (2.5 mEq/L) Peritoneal Dialysis Solution with 1.5% Dextrose, 2000 mL UltraBag container bag, Rx only; Baxter Healthcare Corporation, Deerfield, IL 60015; Product Code 5B9766, NDC 0941-0424-52.
Lack of Assurance of Sterility: Confirmed customer complaints for leaks on the tubing.
- 2019-01-16FDA-DrugGlenmark Pharmaceuticals Inc., USAClass IIEstradiol Vaginal Inserts, USP, 10 mcg, Rx only, packaged in a) 8 count (NDC 68462-711-71) and b) 18 count (NDC 68462-711-88) cartons, Manufactured by: Glenmark Pharmaceuticals, Ltd., Colvale, Goa India, Manufactured for: Glenmark Pharmaceuticals, Inc., USA Mahwah, NJ
Defective Delivery System: Customer complaints of malfunctioning plunger of the applicator
- 2019-01-09FDA-DrugHiers Enterprises, LLC dba Northwest Compounding PharmacyClass IILidocaine gel 1%, RX, plastic dropper
Lack of sterility assurance.
- 2019-01-09FDA-DrugHiers Enterprises, LLC dba Northwest Compounding PharmacyClass IIGlutathione liquid, 200mg/ml, Rx
Lack of sterility assurance.
- 2019-01-09FDA-DrugHiers Enterprises, LLC dba Northwest Compounding PharmacyClass IICyclosporin liquid 0.05%, Rx, plastic dropper bottle
Lack of sterility assurance.
- 2019-01-09FDA-DrugHiers Enterprises, LLC dba Northwest Compounding PharmacyClass IICyclosporin liquid 0.2%, Rx, plastic dropper bottle
Lack of sterility assurance.
- 2019-01-09FDA-DrugHiers Enterprises, LLC dba Northwest Compounding PharmacyClass IICyclosporin liquid 0.5%, Rx, plastic dropper bottle
Lack of sterility assurance.
- 2019-01-09FDA-DrugHiers Enterprises, LLC dba Northwest Compounding PharmacyClass IICyclosporin liquid 1%, Rx, plastic dropper bottle
Lack of sterility assurance.
- 2019-01-09FDA-DrugHiers Enterprises, LLC dba Northwest Compounding PharmacyClass IIVitamin B12 liquid 1000mcg/ml, RX, glass vial
Lack of sterility assurance.
- 2019-01-09FDA-DrugHiers Enterprises, LLC dba Northwest Compounding PharmacyClass IITestosteron Cypionate liquid 200mg/ml, RX, glass vial
Lack of sterility assurance.
- 2019-01-09FDA-DrugHiers Enterprises, LLC dba Northwest Compounding PharmacyClass IIMethocarbamol liquid 100mg/ml, RX, glass vial
Lack of sterility assurance.
- 2019-01-09FDA-DrugHiers Enterprises, LLC dba Northwest Compounding PharmacyClass IIMIC B vitamin liquid 25/50/50/1/1/1mg/ml RX glass vial
Lack of sterility assurance.
- 2019-01-09FDA-DrugHiers Enterprises, LLC dba Northwest Compounding PharmacyClass IILidocaine/Epinepherine liquid 1%/ 1:1000, RX, glass vial These include injectable medications, sterile solutions, eye drops, and eye ointments
Lack of sterility assurance.
- 2019-01-09FDA-DrugHiers Enterprises, LLC dba Northwest Compounding PharmacyClass IILidocaine gel 2%, RX, plastic dropper
Lack of sterility assurance.
- 2019-01-09FDA-DrugHiers Enterprises, LLC dba Northwest Compounding PharmacyClass IIHydroxyprogesterone liquid, 250mg/ml, RX, glass vial
Lack of sterility assurance.
- 2019-01-09FDA-DrugHiers Enterprises, LLC dba Northwest Compounding PharmacyClass IIHCG liquid, 1000u/ml, RX, glass vial, various
Lack of sterility assurance.
- 2019-01-09FDA-DrugHiers Enterprises, LLC dba Northwest Compounding PharmacyClass IIGlutathione liquid, 100mg/ml
Lack of sterility assurance.
- 2019-01-09FDA-DrugHiers Enterprises, LLC dba Northwest Compounding PharmacyClass IIEpinephrine liquid 1:1000, RX, glass vial
Lack of sterility assurance.
- 2019-01-09FDA-DrugHiers Enterprises, LLC dba Northwest Compounding PharmacyClass IICyclosporin liquid 2%, Rx, plastic dropper bottle, dry eye
Lack of sterility assurance.
- 2019-01-09FDA-DrugLUPIN SOMERSETClass IINitrofurantoin Oral Suspension, USP, 25mg/5mL, 230 mL bottle, Rx only, Manufactured by: Novel Laboratories, Inc., Somerset, NJ 08873; Manufactured for: Lupin Pharmaceuticals, Inc., Baltimore, MD 21202, NDC 43386-450-11.
Subpotent Drug: Expansion of June 2018 recall of lots S700065 and S700619 due to below specification results for assay.
- 2019-01-02FDA-DrugAdvanced Pharma Inc.Class IPhenylephrine HCl, 1 mg in Sterile Water for Injection, QS 10mL Injectable Solution, 1 mg/10 mL incorrectly labeled as (10 mcg per mL), 10 mL syringe, Rx only, Avella of Houston, 9265 Kirby Dr., Houston, TX 77054, (877) 794-0404; NDC: 42852-802-61.
Labeling: Label Error on Declared Strength: Label incorrectly lists concentration as "10 mcg per mL" rather than the correct concentration of "100 mcg per mL".
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