Drug and pharmaceutical recalls
17628 federal recalls on file. Federal recalls for prescription drugs, OTC medications, supplements, and pharmaceuticals. Sourced from the FDA and translated into plain English.
- 2017-01-04FDA-DrugRaritan Pharmaceuticals, Inc.Class IICVS Health Homeopathic Infants Teething Tablets 135 count bottle Distributed by: CVS Pharmacy, Inc. One CVS Drive, Woonsocket, RI 02895 NDC 59779-860-03 UPC 0504284162
CGMP Deviations
- 2016-12-28FDA-DrugSage Products LLCClass II2% Chlorhexidine Gluconate* Cloth, 2 disposable cloths per package, further packaged into 96 packages per case, labeled as a) Reorder #9705, b) Reorder #9701-P, and c) Reorder #9780, Sage Products LLC 3909 Three Oaks Road, Cary, Illinois 60013, NDC 53462-705-20.
CGMP Deviations: potential contamination of products manufactured on the same equipment and lines as the contaminated product.
- 2016-12-28FDA-DrugSage Products LLCClass IICOMFORT SHIELD (dimethicone) Barrier Cream Cloths, 3%, packaged as impregnated cloths wrapped in flexible packaging, further packed into inner cartons, with the inner cartons are placed into an over shipper sold in a) 3-count disposable barrier cloths per package, 45 packages per carton, 2 cartons (90 packages) per case, Reorder # 7503, NDC 53462-915-50; b) 8-count disposable barrier cloths per package, 24 packages per carton, 2 cartons (48 packages) per case, Reorder # 7905, NDC 53462-915-80;
CGMP Deviations: potential contamination of products manufactured on the same equipment and lines as the contaminated product.
- 2016-12-28FDA-DrugSage Products LLCClass ICOMFORT SHIELD (dimethicone) Barrier Cream Cloths, 3%, packaged as impregnated cloths wrapped in flexible packaging, further packed into inner cartons, with the inner cartons are placed into an over shipper sold in a) 3-count disposable barrier cloths per package, 45 packages per carton, 2 cartons (90 packages) per case, Reorder # 7503, NDC 53462-915-50; b) 8-count disposable barrier cloths per package, 24 packages per carton, 2 cartons (48 packages) per case, Reorder # 7905, NDC 53462-915-80;
Microbial Contamination of Non-Sterile Products: contamination with the bacteria, Burkholderia cepacia.
- 2016-12-28FDA-DrugTown and Country Compounding and Consultation ServicesClass ISermorelin/GHRP-6 Injection 6 mg-3 mg Lyophylized I, 2 mL vial, Rx, Town and Country Compounding and Consultation Services, Ridgewood, NJ 074502
Non-Sterility; microbial contamination identified as Bacillus circulans
- 2016-12-28FDA-DrugMeta Pharmacy ServicesClass IIPhenylephrine 2.5% + Tropicamide 1% Compounded Eye Drops Solution, 5 mL bottles, Meta Pharmacy Services. NDC 99999-0106-99 Sterile compounded drug, Hospital/office use only, Not for resale Storage: ROOM TEMP
Lack of Sterility Assurance
- 2016-12-28FDA-DrugAmgen, Inc.Class IIAMGEN Kyprolis (carfilzomib) for injection, 30 mg per vial, Discard unused portion, For Intravenous Administration Only, Rx Only, Manufactured for: Onyx Pharmaceuticals, Inc., Thousand Oaks, CA 91320-1799, U.S.A., NDC 76075-102-01
Lack of Assurance of Sterility: Potential cracks in glass vials
- 2016-12-28FDA-DrugLes Emballages Knowlton Inc.Class IIIToms of Maine Naturally Dry Natural Powder Antiperspirant Stick, Distributed by: Tom's of Maine, Kennebunk, ME 04043, Made in Canada, Unit UPC: 077326831953 Case UPC: 10077326831950
Labeling: Label Mix Up- Incorrect back label applied to the product.
- 2016-12-28FDA-DrugInventia Healthcare Private LimitedClass IIDuloxetine Delayed-release Capsules USP 30 mg 30-count bottles, Rx Only, Manufactured by: Inventia Healthcare Private Limited Additional Ambermath M.I.D.C., Ambermath (East) 421506, INDIA, Distributed by: Cipia USA, Inc., Miami, FL 33156, NDC 69097-298-02
Failed Tablet/Capsule Specifications: Capsule shell (s) opening inside the bottle The Initial reports stated one or two capsules in a bottle count of 30s opening. First report came in June 14, 2016. Till date about 22 reports have come in from pharmacies which report two batches 130/16/001 and 130/16/002. Third batch 130/16/003 is not distributed yet, will be recalled from warehouse.
- 2016-12-28FDA-DrugLove My Tru BodyClass ISkinny Bee Diet capsules, 500 mg, packaged in a 60-count bottle
Marketed without an approved NDA/ANDA: presence of undeclared sibutramine, desmethylsibutramine (an active metabolite of sibutramine) and phenolphthalein.
- 2016-12-28FDA-DrugMaking It a LifestyleClass II3rd DEGREE capsules, 60-count bottles, Manufactured for: Making it A Lifestyle, L.L.C.
Marketed without an approved NDA/ANDA - presence of undeclared sibutramine.
- 2016-12-28FDA-DrugMaking It a LifestyleClass IBLACK GOLD X ADVANCED capsules, 60-count bottles, Manufactured for: Making it A Lifestyle, L.L.C.
Marketed without an approved NDA/ANDA - presence of undeclared sibutramine.
- 2016-12-28FDA-DrugMaking It a LifestyleClass IBLACK LABEL X capsules, 60-count bottles, Manufactured for: Making it A Lifestyle, L.L.C.
Marketed without an approved NDA/ANDA - presence of undeclared sildenafil.
- 2016-12-28FDA-DrugUS Compounding IncClass IDocusate Oral 10 mg/mL Oral Syringe, packaged in a) 1 mL (62295-0601-01), b) 2 mL ( 62295-0601-02), and c) 5 mL syringes (62295-0601-05), US Compounding, Conway, AR
Microbial Contamination of Non-Sterile Products; microbial contamination with B. cepacia
- 2016-12-28FDA-DrugHospira Inc., A Pfizer CompanyClass IBupivacaine Hydrochloride Inj., USP (2.5 mg/mL) 0.25%, packaged in 30 mL Single-dose Preservative-Free vials, Rx Only, Hospira, Inc., Lake Forest, IL 60045, NDC 0409-1159-02
Presence of particulate matter: Confirmed customer report for the presence of particulate matter within a single vial.
- 2016-12-28FDA-DrugNovo Nordisk IncClass IGlucaGen HypoKit (glucagon [rDNA origin] for injection), 1 mg per vial, Single use only, Rx Only, Manufactured by: Novo Nordisk A/S 2880 Bagsvaerd, Denmark, NDC 0169-7065-15
Defective delivery system: detached needles on the syringe in the kit.
- 2016-12-28FDA-DrugSperian Eye & Face Protection, IncClass IHoneywell eyesaline Eyewash Sterile Isotonic Solution, sterile water 99%, 32 fl. oz. (946 ml.), Sperian Eye & Face Protection, Inc. (a Honeywell Company), Platteville, WI 53818
Non Sterility; contaminated with Klebsiella pneumoniae
- 2016-12-28FDA-DrugImpax Laboratories, Inc.Class ILamotrigine Orally Disintegrating Tablets (ODT), 200 mg, 30 Tablets 3 blisters containing 10 tablets each, Rx only, Manufactured by: Watson Pharma Private Ltd., Verna, Salcette Goa INDIA, Distributed by: Impax Generics, Hayward, CA
Labeling; Label Mixup; box labeled to contain 200 mg blister packs but actually contain 100 mg blister packs
- 2016-12-28FDA-DrugVIRTUS PHARMACEUTICALS OPCO II LClass IHyoscyamine Sulfate, USP Tablets, 0.125 mg, 100-count tablets per bottle, Rx only, Manufactured for: Virtus Pharmaceuticals OPCO II, LLC., Nashville, TN 37217, NDC 76439-308-10.
Failed Content Uniformity Specifications: resulting in both superpotent and subpotent tablets.
- 2016-12-28FDA-DrugVIRTUS PHARMACEUTICALS OPCO II LClass IHyoscyamine Sulfate, Orally Disintegrating Tablets, 0.125 mg, 100-count bottles, Rx only, Manufactured for: Virtus Pharmaceuticals OPCO II, LLC., Nashville, TN 37217, NDC 76439-307-10.
Failed Content Uniformity Specifications: resulting in both superpotent and subpotent tablets.
- 2016-12-28FDA-DrugVIRTUS PHARMACEUTICALS OPCO II LClass IHyoscyamine Sulfate, Sublingual Tablets, 0.125 mg, 100-count bottle, Rx only, Manufactured for: Virtus Pharmaceuticals OPCO II, LLC., Nashville, TN 37217, NDC 76439-309-10.
Failed Content Uniformity Specifications: resulting in both superpotent and subpotent tablets.
- 2016-12-28FDA-DrugGuardian Pharmacy ServicesClass ILidocaine HCL/ Sodium Bicarb, 1%/0.5% 0.5 mL SYR PF, packaged in a 3 cc pre-filled syringe, Rx only
Non-Sterility: failed sterility test result.
- 2016-12-28FDA-DrugUltimate Body ToxClass IUltimate Body Tox PRO capsules, Proprietary Blend, 350 mg, 45 count bottle, Manufactured for: JSN Health, 305 Broadway, 7th Floor, New York, NY 10007.
Marketed Without An Approved NDA/ANDA: The product contains undeclared sibutramine. The presence of sibutramine, a previously approved controlled substance that was removed from the U.S. market in October 2010 for safety reasons, in this tainted product renders it an unapproved drug for which safety and efficacy have not been established and therefore subject to recall.
- 2016-12-28FDA-DrugColonia Care PharmacyClass IIC-PAV/PHENTOL/ATROP/PGE1, All strengths, All sizes, Rx only, Colonia Care Pharmacy, Colonia NJ 07067
Lack of Assurance of Sterility; sterility concerns with all injectable drug products that were made with sterilized filtered stock solutions.
- 2016-12-28FDA-DrugColonia Care PharmacyClass IIC-PAV/PHENTOL/PGE1, All strengths, All sizes, Rx only, Colonia Care Pharmacy, Colonia NJ 07067
Lack of Assurance of Sterility; sterility concerns with all injectable drug products that were made with sterilized filtered stock solutions.
- 2016-12-28FDA-DrugZydus Pharmaceuticals USA IncClass IIIBuPROPion Hydrochloride Extended-Release Tablets (XL), 300 mg, Rx Only, a) 30 count bottles (NDC 68382-354-06) and b) 500 count bottles (NDC 68382-354-05), Manufactured by: Cadila Healthcare LTD. Ahmedabad, India Distributed by: Zydus Pharmaceuticals USA Inc. Pennington, NJ 08534
Failed Dissolution Specifications; 6 month time point
- 2016-12-28FDA-DrugBaxter Healthcare CorporationClass IIFluconazole Injection, USP, 200 mg/100 mL (2mg/mL), 100 mL Single-Dose Intravia Container bag, Rx only, Baxter Healthcare Corporation, Deerfield, IL 60015 USA, Product Code 2J1446, NDC 0338-6046-48.
Lack of Assurance of Sterility: confirmed customer complaints of leaking bags.
- 2016-12-21FDA-DrugJubilant Cadista Pharmaceuticals, Inc.Class IIIMethylprednisolone Tablets, USP, 16 mg, 50-count bottles, Rx only, Manufactured by Jubilant Cadista Pharmaceuticals Inc., Salisbury, MD 21801, NDC 59746-003-14.
Labeling: Incorrect or Missing Lot and/or Exp Date: incorrect expiration date of 02/0218 is printed on the container label instead of the correct expiration date of 02/2018.
- 2016-12-21FDA-DrugCantrell Drug CompanyClass IISuccinylcholine Chloride 200 mg/10 mL Injection Solution 10 mL (20 mg/mL) ,Single-Dose Syringe Injection Solution, For Slow IV Use Only ,Rx Only, Cantrell Drug Company 7321 Cantrell Rd Little Rock, AR 72207, NDC 52533-067-12
Lack of Assurance of Sterility - the firm is recalling select sterile drug products.
- 2016-12-21FDA-DrugCantrell Drug CompanyClass IIRopivacaine HCl 0.25% in 0.9% Sodium Chloride, 100 mL Bag, Epidural Use Only, Rx Only, Cantrell Drug Co. 7321 Cantrell Road Little Rock, AR 72207, NDC 52533-185-75
Lack of Assurance of Sterility - the firm is recalling select sterile drug products.
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