FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
3CS ORGANICS LLC
- Product
- HOLLE Bio Zulgelingen Opvolgmelk 2, (3/case), HOLLE Bio Lait…
- Reason
- The product is not FDA approved and not all products are labeled in English.
- Published
- July 19, 2017
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
3CS ORGANICS LLC
- Product
- HIPP HA Combiotik HA 1, 500g (4/case), HIPP Combiotik HA 2,…
- Reason
- The product is not FDA approved and not all products are labeled in English.
- Published
- July 19, 2017
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
3CS ORGANICS LLC
- Product
- HIPP Bio Combiotik 1, Canister, 900g (4/case), HIPP Bio Co…
- Reason
- The product is not FDA approved and not all products are labeled in English.
- Published
- July 19, 2017
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
VenomX, Zinc acetate (.1% by volume), 0.3 fl. oz. (3 mL) bottles, Skin Protectant Phillips Company, Millerton, OK -- NDC 43074-207-01
by Phillips Co.
- Reason
- GMP Deviations; FDA inspection found significant manufacturing practices that call into question the safety, identity, strength, quality and purity of unexpired drug products manufactured by the firm.
- Published
- July 12, 2017
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
StaphWash+Plus+ Skin Protectant, Zinc acetate (.1% by volume), 0.3 fl. oz. (3 mL) bottle, Phillips Company, Millerton, OK -- NDC 43074-101-01
by Phillips Co.
- Reason
- GMP Deviations; FDA inspection found significant manufacturing practices that call into question the safety, identity, strength, quality and purity of unexpired drug products manufactured by the firm.
- Published
- July 12, 2017
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
StingMed Insect bites Skin Protectant. Zinc acetate (.1% by volume), 0.3 fl. oz. (3 mL) bottle, Phillips Company, Millerton, OK -- NDC 04307-100-11
by Phillips Co.
- Reason
- GMP Deviations; FDA inspection found significant manufacturing practices that call into question the safety, identity, strength, quality and purity of unexpired drug products manufactured by the firm.
- Published
- July 12, 2017
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Diabecline brand Topical Ointment First Aid Antibiotic, tetracycline (3%), 3 mL in a 5 mL bottle, sold over the counter Phillips Company, Millerton, OK -- NDC 04307-100-11
by Phillips Co.
- Reason
- GMP Deviations; FDA inspection found significant manufacturing practices that call into question the safety, identity, strength, quality and purity of unexpired drug products manufactured by the firm.
- Published
- July 12, 2017
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
TetraStem brand Topical Ointment First Aid Antibiotic, tetracycline (3%), 3 mL in a 5 mL bottle, sold over the counter Phillips Company, Millerton, OK -- NDC 04307-301-11
by Phillips Co.
- Reason
- GMP Deviations; FDA inspection found significant manufacturing practices that call into question the safety, identity, strength, quality and purity of unexpired drug products manufactured by the firm.
- Published
- July 12, 2017
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Tetracycline-ABC Brand Topical ointment First Aid Antibiotic, tetracycline (3%), 3 mL in a 5 mL bottle, sold over the counter Phillips Company, Millerton, OK -- NDC 4307410201
by Phillips Co.
- Reason
- GMP Deviations; FDA inspection found significant manufacturing practices that call into question the safety, identity, strength, quality and purity of unexpired drug products manufactured by the firm.
- Published
- July 12, 2017
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Succinylcholine Chloride, 100 mg per 5mL, 20 mg per mL syringe. IV Use Only. JCB Laboratories, 8710 E 34th St., N. Wichita, KS 67226 UPC 7335968405
by Fagron Compounding Services LLC dba Fagron Sterile Services
- Reason
- Lack Of Assurance Of Sterility: voluntary recall initiated by the commercial supplier
- Published
- July 12, 2017
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass III
G & W Clobetasol Propionate Ointment 0.05%, packaged in a) 15 g tube (NDC 0713-0656-15), b) 30 g tube (NDC 0713-0656-31, c) 45 g tube (NDC 0713-0656-37), d) 60 g tube (NDC 0713-0656-60), Rx Only, Manufactured by G & W Laboratories, Inc. 111 Coolidge Street, South Plainfield, NJ 07080
by G & W Laboratories, Inc.
- Reason
- Failed impurities/degradation specifications: This product is being recalled due to out of specification results for Clobetasol Related Compound A, a known impurity which is a degradation product.
- Published
- July 12, 2017
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
parodontax WHITENING (Stannous fluoride) Daily Fluoride Anticavity and Antigingivitis Toothpaste, 0.454% (0.15% w/v fluoride ion), 3.4 OZ (96.4 g) tube, Distributed by: GSK Consumer Healthcare, Warren, NJ 07059, NDC 0135-0601-01.
by GSK Consumer Healthcare
- Reason
- Presence of Foreign Substance: possibility of the presence of metal in the product.
- Published
- July 12, 2017
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Clindamycin Injection USP; 900 mg/6 mL (150 mg/mL). 6 mL Single-dose ADD-VANTAGE Vial, Rx Only, Manufactured for Alvogen, Inc., Pine Brook, NJ 07058, NDC 47781-464-69
by Alvogen, Inc
- Reason
- Lack of Assurance of Sterility
- Published
- July 12, 2017
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Clindamycin Injection USP; 600 mg/4 mL (150 mg/mL). 4 mL Single-dose ADD-VANTAGE Vial, Rx Only, Manufactured for Alvogen, Inc., Pine Brook, NJ 07058, NDC 47781-463-69
by Alvogen, Inc
- Reason
- Lack of Assurance of Sterility
- Published
- July 12, 2017
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Clindamycin Injection USP; 300 mg/2 mL (150 mg/mL). 2 mL Single-dose ADD-VANTAGE Vial, Rx Only, Manufactured for Alvogen, Inc., Pine Brook, NJ 07058, NDC 47781-462-69
by Alvogen, Inc
- Reason
- Lack of Assurance of Sterility
- Published
- July 12, 2017
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Methocarbamol, USP, packaged in a) 100 g container (NDC: 58597-8023-6, b) 500 g container (NDC: 58597-8023-7), c) 1,000 g container (NDC: 58597-8023-8). For Prescription Compounding RX Only. Packed under cGMP conditions by American Pharmaceutical Ingredients, LLC 6650 Highland Road, Waterford, MI 48327
by American Pharmaceutical Ingredients LLC
- Reason
- CGMP Deviations: Lack of quality assurance at the API manufacturer.
- Published
- July 12, 2017
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass III
Bupivacaine HCl 0.25% 400 mL Total Volume in an ON-Q Pump in 0.9% Sodium Chloride Injection in 400 mL, Rx Only, Compounded by PharMEDium Services, LLC, Sugar Land, TX 77478, NDC: 61553-023-09
by Pharmedium Services Llc
- Reason
- Labeling: Incorrect or Missing Lot and/or Exp Date
- Published
- July 12, 2017
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass III
Bupivacaine HCl 0.25% 270 mL Total Volume in an ON-Q Pump in 0.9% Sodium Chloride Injection in 270 mL, Rx Only, Compounded by PharMEDium Services, LLC, Sugar Land, TX 77478, NDC: 61553-044-57
by Pharmedium Services Llc
- Reason
- Labeling: Incorrect or Missing Lot and/or Exp Date
- Published
- July 12, 2017
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass III
Ropivacaine HCl 0.2% 550 mL Total Volume in an AutoFuser Pump in 0.9% Sodium Chloride Injection, Rx Only, Compounded by PharMEDium Services, LLC, Sugar Land, TX 77478, NDC: 61553-100-13
by Pharmedium Services Llc
- Reason
- Labeling: Incorrect or Missing Lot and/or Exp Date
- Published
- July 12, 2017
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass III
Ropivacaine HCl 0.2% 750 mL Total Volume in an ON-Q Pump in 0.9% Sodium Chloride Injection in 600 mL, Rx Only, Compounded by PharMEDium Services, LLC, Sugar Land, TX 77478, NDC: 61553-279-33
by Pharmedium Services Llc
- Reason
- Labeling: Incorrect or Missing Lot and/or Exp Date
- Published
- July 12, 2017
- Distribution
- Nationwide
View recall →
Recall records are summarized from official FDA and USDA sources. Notices may be updated, reclassified, terminated, or withdrawn. Always review the linked official notice for the most current instructions.
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