FDA Recall
Ongoing
Historical recordClass II
BCAA (30 ML) (Isoleucine (L) 15 mg + Leucine (L) 10 mg+ Valine 40 mg+ Lidocaine HCL 10 mg/mL). Compounded by Tri-Coast Pharmacy.
by Tri-Coast Pharmacy
- Reason
- Lack of Assurance of Sterility
- Published
- January 11, 2017
- Distribution
- Nationwide
View recall →
FDA Recall
Ongoing
Historical recordClass II
Ascorbic Acid 500 mg/mL (50 ML). Compounded by Tri-Coast Pharmacy.
by Tri-Coast Pharmacy
- Reason
- Lack of Assurance of Sterility
- Published
- January 11, 2017
- Distribution
- Nationwide
View recall →
FDA Recall
Ongoing
Historical recordClass II
Amino Acid Recover Eaze (50 ML), Phenylaline (L) 8 mg/ml + Tyrosine (L) 0.45 mg/ml + L-Taurine 0.7 mg/ml. Compounded by Tri-Coast Pharmacy.
by Tri-Coast Pharmacy
- Reason
- Lack of Assurance of Sterility
- Published
- January 11, 2017
- Distribution
- Nationwide
View recall →
FDA Recall
Ongoing
Historical recordClass II
Amino Energy Cocktail (30 ML), (Methionine (L) 12.5 mg/Inositol 25 mg/Choline Chloride 25 mg/Methylcobalamin 300 mcg/Carnitine (L) 125 mg/Thiamine HCL 50 mg/Riboflavin-5-Phosphate Sod 5 mg/Niacinamide 20 mg/Pyridoxine HCL 2 mg/Folic Acid 2 mg/Ascorbic Acid 50 mg/Chromium Picolinate 200 mcg/Glutamine (L) 30 mg/Lidocaine HCL 10 mg/mL). Compounded by Tri-Coast Pharmacy.
by Tri-Coast Pharmacy
- Reason
- Lack of Assurance of Sterility
- Published
- January 11, 2017
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Sermorelin Acetate/GHRP (2) 9 mg/3 mg Injectable Kit, Compounded by Wells Pharmacy, Ocala FL
by Wells Pharmacy Network LLC
- Reason
- Lack of Assurance of Sterility
- Published
- January 11, 2017
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
QUAD1(PAP/PHEN/ALPROS/ATRO) 0.9 mg/0.2 mg/20 mcg/0.01 mg/mL Injectable, a) 2 mL and b) 5 mL vials, Compounded by Wells Pharmacy, Ocala, FL
by Wells Pharmacy Network LLC
- Reason
- Lack of Assurance of Sterility
- Published
- January 11, 2017
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Testosterone Cypionate in Sesame Oil Injectable, 210 mg/mL, 10 mL vial, Compounded by Wells Pharmacy, Ocala, FL
by Wells Pharmacy Network LLC
- Reason
- Lack of Assurance of Sterility
- Published
- January 11, 2017
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Alprostadil 20 mcg/mL Injectable, a) 5 mL and b) 10 mL vials, Compounded by Wells Pharmacy Network LLC, Ocala FL
by Wells Pharmacy Network LLC
- Reason
- Lack of Assurance of Sterility
- Published
- January 11, 2017
- Distribution
- Nationwide
View recall →
FDA Recall
Ongoing
Historical recordClass II
Ultra Amino Blend (Arginine HCL 105 mg + Lysine (L) HCL 150 mg + Ornithine (L) HCL 75 mg + Glutamine (L) 75 mg/ml + Lidocaine HCL 10 mg/mL), (30 ML). Compounded by Tri-Coast Pharmacy
by Tri-Coast Pharmacy
- Reason
- Lack of Assurance of Sterility
- Published
- January 11, 2017
- Distribution
- Nationwide
View recall →
FDA Recall
Ongoing
Historical recordClass II
TriMix, Alprostadil/Phentolamine/Papaverine 40mcg/2mg/60mg/mL, (1 ML). Compounded by Tri-Coast Pharmacy
by Tri-Coast Pharmacy
- Reason
- Lack of Assurance of Sterility
- Published
- January 11, 2017
- Distribution
- Nationwide
View recall →
FDA Recall
Ongoing
Historical recordClass II
Testosterone Propionate 100 mg/mL, (5 ML). Compounded by Tri-Coast Pharmacy
by Tri-Coast Pharmacy
- Reason
- Lack of Assurance of Sterility
- Published
- January 11, 2017
- Distribution
- Nationwide
View recall →
FDA Recall
Ongoing
Historical recordClass II
Lipotropic (L-Carnitine 170 mg + Methylcobalamin 300 mcg + Thiamine HCL 20 mg + Riboflavin-5-phosphate Sod 2 mg + Niacinamide 20 mg + Pyridoxine HCL 2 mg + Folic Acid 1 mg/Lidocaine HCL 10 mg/ml), (30 ML). Compounded by Tri-Coast Pharmacy
by Tri-Coast Pharmacy
- Reason
- Lack of Assurance of Sterility
- Published
- January 11, 2017
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass III
VirtPrex Prenatal/Postnatal Tablets, Prescription Supplement Containing Folic Acid and DHA, packaged in 30-count bottle, Rx only, Made in Canada, NDC 76439-348-30
by VIRTUS PHARMACEUTICALS OPCO II L
- Reason
- cGMP Deviations: Active Pharmaceutical Ingredient (API) manufacturer is on FDA Import Alert.
- Published
- January 4, 2017
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass III
Virt-Select Prenatal/Postnatal Softgels, Prescription Multivitamin/Mineral Dietary Supplement with Fish-Based DHA , packaged in 30-count bottle, Rx only, Made in Canada, NDC 76439-249-30
by VIRTUS PHARMACEUTICALS OPCO II L
- Reason
- cGMP Deviations: Active Pharmaceutical Ingredient (API) manufacturer is on FDA Import Alert.
- Published
- January 4, 2017
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass III
Extra-Virt Plus DHA Prenatal/Postnatal Softgel, Prescription Multivitamin/Mineral Dietary Supplement with Fish-Based DHA , packaged in 30-count bottle, Rx only, Made in Canada, NDC 76439-251-30
by VIRTUS PHARMACEUTICALS OPCO II L
- Reason
- cGMP Deviations: Active Pharmaceutical Ingredient (API) manufacturer is on FDA Import Alert.
- Published
- January 4, 2017
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass III
Virt-Advance Prenatal/Postnatal Softgels, Prescription Folic Acid Containing Dietary Supplement, packaged in 90-count bottle, Rx only, Made in Canada, NDC 76439-357-90
by VIRTUS PHARMACEUTICALS OPCO II L
- Reason
- cGMP Deviations: Active Pharmaceutical Ingredient (API) manufacturer is on FDA Import Alert.
- Published
- January 4, 2017
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass III
Techni-Care Surgical Hand Scrub and Patient Preoperative Skin Preparation (3.0% w/v Chloroxylenol), packaged in a) 4 oz. bottles (NDC 46706-201-01), b) 8 oz bottles (NDC 46706-201-02), c) 16 oz. bottles (NDC 46706-201-03), d) 12 oz. pumpette (NDC 46706-201-05), e) 32 oz. bottles (NDC 46706-201-06), OTC, Care-Tech Laboratories, Inc., St. Louis, MO 63139
by Care-Tech Laboratories, Inc.
- Reason
- Labeling: Incorrect or Missing Lot and/or Exp Date - Product is missing or has illegible lot and expiry codes, as well as defective or cracked caps.
- Published
- January 4, 2017
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
Bio-Botanica, Inc.
- Product
- Liquid VITAMIN D-3 Drops distributed under the following pri…
- Reason
- The lots exceed the label claim for Vitamin D3 of 2000 IU per drop.
- Published
- January 4, 2017
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass I
Cargill Cocoa & Chocolate, Inc.
- Product
- Wilbur; IM10021; B558 Semisweet Chocolate Drops, 2000 CT; Ne…
- Reason
- Cargill Cocoa & Chocolate is recalling 50 lb. cartons of Wilbur B558 Semi-Sweet Chocolate Drops because it may contain undeclared milk.
- Published
- January 4, 2017
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
COMFORT 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; c) 3-count disposable barrier cloths per package, 50 packages per carton, 2 cartons (100 packages) per case, Reorder # 7502, NDC 53462-915-51; d) 8-count disposable barrier cloths per package, 24 packages per carton, 2 cartons (48 packages) per case, Reorder # 7508, NDC 53462-915-81; e) 24-count disposable barrier cloths per tub, 12 packages per case, Reorder # 7524, NDC 53462-915-60; f) 24-count disposable barrier cloths per package, 9 packages per carton, 2 cartons (18 packages) per case, Reorder # 7526, NDC 53462-0915-62; Sage Products LLC, 3909 Three Oaks Road, Cary, Illinois 60013.
by Sage Products LLC
- Reason
- CGMP Deviations: potential contamination of products manufactured on the same equipment and lines as the contaminated product.
- Published
- December 28, 2016
- 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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