Drug and pharmaceutical recalls
17624 federal recalls on file. Federal recalls for prescription drugs, OTC medications, supplements, and pharmaceuticals. Sourced from the FDA and translated into plain English.
- 2019-08-21FDA-DrugInfusion Options, Inc.Class IIAZACITIDINE 125 MG / 5 ML SUB-Q SYRINGE; AZACITIDINE 75 MG (3 ML) SYRINGE, AZACITIDINE 135 MG / 5.4 ML SUB-Q SYRINGE, Rx Only, Infusion Options, Inc. 5924 13the Ave, Brooklyn, NY 11219-4934, 718-283-7233
Lack of Assurance of Sterility
- 2019-08-21FDA-DrugInfusion Options, Inc.Class IIAVASTIN 630 MG / 100 ML 0.9% NACL IVPB; AVASTIN 2.5 mg/ 0.1ML Syringe; AVASTIN 587.5 MG/100 ML 0.9% NACL IVPB; AVASTIN 350 MG/100 ML 0.9% NACL IVPB; AVASTIN 325 MG / 100 ML 0.9% NACL IVPB; AVASTIN 3.75 mg/ 0.15 ML Syringe; AVASTIN 416 MG / 100 ML 0.9% NACL IVPB; AVASTIN 360 MG/100 ML 0.9% NACL IVPB; AVASTIN 250 MG / 100 ML 0.9% NACL IVPB; AVASTIN 693.125 MG/100 ML 0.9% NACL IVPB; AVASTIN 1020 MG/100 ML NS IVPB; AVASTIN 811.875 MG/100 ML 0.9% NACL IVPB; AVASTIN 1006.25 MG/100 ML NS IVPB, Rx On
Lack of Assurance of Sterility
- 2019-08-21FDA-DrugInfusion Options, Inc.Class IIATEZOLIZUMAB 1200 MG / 250 ML 0.9% NACL, Rx Only, Infusion Options, Inc. 5924 13the Ave, Brooklyn, NY 11219-4934, 718-283-7233
Lack of Assurance of Sterility
- 2019-08-21FDA-DrugInfusion Options, Inc.Class IIALIMTA 785 mg QS 100 ml 0.9% NACL IVPB; ALIMTA 1000 mg QS 100 ml 0.9% NACL IVPB; Rx Only, Infusion Options, Inc. 5924 13the Ave, Brooklyn, NY 11219-4934, 718-283-7233
Lack of Assurance of Sterility
- 2019-08-21FDA-DrugInfusion Options, Inc.Class IIADO-TRASTUZUMAB 210 MG/250 ml NS; ADO-TRASTUZUMAB E 213 MG / 250 ML NS; ADO-TRASTUZUMAB 242 MG/250 ml NS; ADO-TRASTUZUMAB EMT 168 mg / 250 ml NS; ADO-TRASTUZUMAB E 160 MG / 250 ML NS ADO-TRASTUZUMAB 150 mg / 250 ml NS; ADO-TRASTUZUMAB EMT 301 mg / 250 ml NS; ADO-TRASTUZUMAB EMTANSINE 230mg/250ml NS IV Rx Only, Infusion Options, Inc. 5924 13the Ave, Brooklyn, NY 11219-4934, 718-283-7233
Lack of Assurance of Sterility
- 2019-08-21FDA-DrugInfusion Options, Inc.Class IIAdcetris 96 MG/100 ML NS IVPB, Rx Only, Infusion Options, Inc. 5924 13the Ave, Brooklyn, NY 11219-4934, 718-283-7233
Lack of Assurance of Sterility
- 2019-08-21FDA-DrugInfusion Options, Inc.Class IIAbraxane 170 MG / 34 ML IVPB; Abraxane 200 MG / 40 ML IVPB; Abraxane 180 MG / 36 ML IVPB, Rx Only, Infusion Options, Inc. 5924 13the Ave, Brooklyn, NY 11219-4934, 718-283-7233
Lack of Assurance of Sterility
- 2019-08-21FDA-DrugInfusion Options, Inc.Class IIOxytocin 60 units/1000 mL Lactated Ringers Intravenous Solution, Rx Only, Infusion Options, Inc. 5924 13the Ave, Brooklyn, NY 11219-4934, 718-283-7233
Lack of Assurance of Sterility
- 2019-08-21FDA-DrugGlenmark Pharmaceuticals Inc., USAClass IIIClotrimazole and Betamethasone Dipropionate Cream USP, 1%/0.05%, 15 gram tubes, Rx only, Manufactured by: Glenmark Pharmaceuticals Ltd. Village: Kishanpura, Baddi Nalagarth Road, District: Solan, Himachal Pradesh-173205, India. Manufactured for: Glenmark Pharmaceuticals Inc., USA Mahwah, NJ 07430, NDC 68462-298-17
Temperature Abuse: Complaints received of liquidy texture.
- 2019-08-21FDA-DrugUS Pharmaceuticals Inc.Class IICRYO-273 Cold Pain Relieving Gel 128 FL. OZ. Distributed By: CRYO-273.com Tampa, FL 33629. UPC 8 15290 01550 2
CGMP Deviations: Out of Specification results for either total microbial count or total organic carbon in the purified water utilized in the manufacturing process.
- 2019-08-21FDA-DrugUS Pharmaceuticals Inc.Class IIWonder Freeze Pain Releiving Gel with ILEX, Menthol 5%, packaged in a) 3 OZ /85 g (UPC 0 99528 35903 5); b) 4 OZ / 113 g (UPC 0 99528 31504 8); c) 16 OZ / 454 g (UPC 0 99528 31516 1); Manufactured For: Wonder Laboratories, 115 S.C.T. Ct., White House TN. 37188.
CGMP Deviations: Out of Specification results for either total microbial count or total organic carbon in the purified water utilized in the manufacturing process.
- 2019-08-21FDA-DrugUS Pharmaceuticals Inc.Class IIKool Comfort Cooling Pain Relief, 5% Menthol, Packaged in a) 3 OZ./85 g (UPC 0 52301 35903 5); b) 4 OZ/ 113 g (UPC 0 52301 36504 3); c) 32 OZ/ 907 g (UPC 0 52301 36532 6); d) 16 OZ/ 454 g (UPC 0 52301 36516 6); e) 128 OZ/ 3629 g (UPC 0 52301 36512 8) Manufactured for: Dee Cee Laboratories, Inc. 304 Dee Cee Rd., White House, TN 37188.
CGMP Deviations: Out of Specification results for either total microbial count or total organic carbon in the purified water utilized in the manufacturing process.
- 2019-08-21FDA-DrugUS Pharmaceuticals Inc.Class IICool Hot Ice Analgesic Gel, 8 oz (227 g) Distributed by: Unipack Inc. Pittsburg, PA 15239, USA. UPC 7 51393 00608 6
CGMP Deviations: Out of Specification results for either total microbial count or total organic carbon in the purified water utilized in the manufacturing process.
- 2019-08-21FDA-DrugUS Pharmaceuticals Inc.Class IICRYO-273 Cold Pain Relieving Gel Roll-On 3 FL. OZ. (89 mL) Distributed By: CRYO-273.com Tampa, FL 33629. UPC 8 15290 01529 6
CGMP Deviations: Out of Specification results for either total microbial count or total organic carbon in the purified water utilized in the manufacturing process.
- 2019-08-21FDA-DrugUS Pharmaceuticals Inc.Class IICVS Health Glycerin Suppositories, 100- count box, Distributed by:Distributed by: CVS Pharmacy, Inc. One CVS Drive Woonsocket, RI 02895. UPC 0 50428 42738 5
CGMP Deviations: Out of Specification results for either total microbial count or total organic carbon in the purified water utilized in the manufacturing process.
- 2019-08-21FDA-DrugUS Pharmaceuticals Inc.Class IISoothe&Cool Protect Moisture Guard Skin Protectant, 3.5 oz. (99 g), tube, Manufactured for Medline industries, Inc., Mundelein, IL 60060. NDC 53329-303-22
CGMP Deviations: Out of Specification results for either total microbial count or total organic carbon in the purified water utilized in the manufacturing process.
- 2019-08-21FDA-DrugUS Pharmaceuticals Inc.Class IIHydrocortisone Cream, Hydrocortisone 1% / Anti-Itch Cream, 2 OZ (56 g) tube. Distributed By: Walgreen Co. 200 Wilmot Rd., Deerfield, IL 60015. NDC #0363-0638-04, UPC 3 11917 18247 6
CGMP Deviations: Out of Specification results for either total microbial count or total organic carbon in the purified water utilized in the manufacturing process.
- 2019-08-21FDA-DrugUS Pharmaceuticals Inc.Class IIHydrocortisone Cream, Hydrocortisone 1% / Anti-Itch Cream, 1 OZ (28 g) tube. Distributed By: Walgreen Co. 200 Wilmot Rd., Deerfield, IL 60015. NDC #0363-0638-03, UPC 3 11917 18245 2 .
CGMP Deviations: Out of Specification results for either total microbial count or total organic carbon in the purified water utilized in the manufacturing process.
- 2019-08-21FDA-DrugUS Pharmaceuticals Inc.Class IIHydrocortisone Cream With Aloe, Hydrocortisone 1% / Anti-Itch Cream with Aloe, 2 OZ (56 g) tube. Distributed By: Walgreen Co. 200 Wilmot Rd., Deerfield, IL 60015. NDC #0363-0620-04, UPC 3 11917 17934 6
CGMP Deviations: Out of Specification results for either total microbial count or total organic carbon in the purified water utilized in the manufacturing process.
- 2019-08-21FDA-DrugUS Pharmaceuticals Inc.Class IIHydrocortisone Cream With Aloe, Hydrocortisone 1% / Anti-Itch Cream with Aloe, 1 OZ (28 g) tube. Distributed By: Walgreen Co. 200 Wilmot Rd., Deerfield, IL 60015. NDC #0363-0620-03, UPC 3 11917 17935 3
CGMP Deviations: Out of Specification results for either total microbial count or total organic carbon in the purified water utilized in the manufacturing process.
- 2019-08-21FDA-DrugUS Pharmaceuticals Inc.Class IIAdult Glycerin Suppositories, Package Size 100-count suppositories, Distributed By: Walgreen Co. 200 Wilmot Rd. Deerfield, IL 60015. NDC#0363-0441-00
CGMP Deviations: Out of Specification results for either total microbial count or total organic carbon in the purified water utilized in the manufacturing process.
- 2019-08-21FDA-DrugUS Pharmaceuticals Inc.Class IIAdult Glycerin Suppositories, Package Size 50-count suppositories, Distributed By: Walgreen Co. 200 Wilmot Rd. Deerfield, IL 60015. NDC#0363-0441-50
CGMP Deviations: Out of Specification results for either total microbial count or total organic carbon in the purified water utilized in the manufacturing process.
- 2019-08-21FDA-DrugUS Pharmaceuticals Inc.Class IIAdult Glycerin Suppositories, Package Size 25-count suppositories, Distributed By: Walgreen Co. 200 Wilmot Rd. Deerfield, IL 60015. NDC#0363-0445-25,
CGMP Deviations: Out of Specification results for either total microbial count or total organic carbon in the purified water utilized in the manufacturing process.
- 2019-08-21FDA-DrugUS Pharmaceuticals Inc.Class IIChildren Glycerin Suppositories Laxative for ages 2 to 5. Package Size 25-count.Distributed by Walgreen CO. 200 Wilmot Rd. Deerfield IL 60015. NDC#0363-0440-25,
CGMP Deviations: Out of Specification results for either total microbial count or total organic carbon in the purified water utilized in the manufacturing process.
- 2019-08-21FDA-DrugUS Pharmaceuticals Inc.Class IICVS Therapeutic Menthol Gel, 8 FL OZ (227 g) Distributed by: CVS Pharmacy, Inc. One CVS Drive Woonsocket, RI 02895. UPC 0 50428 48136 3
CGMP Deviations: Out of Specification results for either total microbial count or total organic carbon in the purified water utilized in the manufacturing process.
- 2019-08-21FDA-DrugUS Pharmaceuticals Inc.Class IIEczema Lotion Hydrocortisone 1% / Anti-Itch Lotion, 3.5 oz (99.2 g) Distributed By: Walgreen Co. 200 Wilmot Rd. Deerfield, IL,60015. NDC 0363-0670-04, UPC 3 11917 19308 3
CGMP Deviations: Out of Specification results for either total microbial count or total organic carbon in the purified water utilized in the manufacturing process.
- 2019-08-21FDA-DrugUS Pharmaceuticals Inc.Class IICVS Health Glycerin Suppositories, 50-count box, Distributed by: CVS Pharmacy, Inc. One CVS Drive Woonsocket, RI 02895. UPC 0 50428 33106 4
CGMP Deviations: Out of Specification results for either total microbial count or total organic carbon in the purified water utilized in the manufacturing process.
- 2019-08-21FDA-DrugAlvogen, IncClass IIMacrobid Urinary Tract Anitbacterial, 100 mg, 100-count bottle, Rx Only, Mfg. by: Norwich Pharmaceuticals, Inc. Norwich, NY 13815 USA Dist. by: Almatica Pharma, Inc. Pine Brook, NJ 07058 USA, NDC 52427-285-01
Failed dissolution specifications
- 2019-08-21FDA-DrugAlvogen, IncClass IINitrofurantoin Monohydrate/Macrycrystals Capsules, 100 mg, 100-count bottle, Rx Only, Distributed by: Alvogen, Inc. Pine Brook, NY 07058 USA, NDC 47781-303-01
Failed dissolution specifications
- 2019-08-21FDA-DrugLupin Pharmaceuticals Inc.Class IILisinopril and Hydrochlorothiazide Tablets USP, 10 mg/12.5 mg, 100 tablet bottle, Rx only, Manufactured by for: Lupin Pharmaceuticals, Inc., Baltimore, MD, Manufactured by: Lupin Limited, Pithampur, INDIA NDC 68180-518-01
Presence of Foreign Substance; Product complaints received related to brownish/blackish stains on the tablets and brownish/blackish powder observed inside the bottles.
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