FDA Recall
Terminated
Historical recordClass II
BEVACIZUMAB 1.25 mg/0.05 mL 31G MJ syringe Intravitreal Injection. This biologic product was repackaged by AmEx Pharmacy 1515 Elizabeth St. Suite J Melbourne, FL 32901 Lot:190212AB BUD:5/13/2019, Repackaged on 2/12/2019
by Pacifico National, Inc. dba AmEx Pharmacy
- Reason
- Defective Delivery System: difficult to express
- Published
- May 8, 2019
- Distribution
- Nationwide
View recall →
FDA Recall
Ongoing
Historical recordClass II
Losartan Potassium and Hydrochlorothiazide Tablets, USP, 100mg/25mg, a) 30-count (NDC: 13668-118-30) b) 90-count (NDC: 13668-118-90), c) 1000-count (NDC: 13668-118-10), per bottle, Rx only, Manufactured by: Torrent Pharmaceuticals LTD, Indrad-382 721, Dist. Mehsana India
by Torrent Pharma Inc.
- Reason
- CGMP Deviations: FDA lab confirmed presence of an impurity, N-Methylnitrosobutyric acid (NMBA) in the finished product above the interim acceptable daily intake level.
- Published
- May 8, 2019
- Distribution
- Nationwide
View recall →
FDA Recall
Ongoing
Historical recordClass II
Losartan Potassium and Hydrochlorothiazide Tablets, USP, 100mg/12.5mg, a) 90-count (NDC: 13668-117-90), b) 1000-count (NDC: 13668-117-10), per bottle, Rx only, Manufactured by: Torrent Pharmaceuticals LTD, Indrad-382 721, Dist. Mehsana India
by Torrent Pharma Inc.
- Reason
- CGMP Deviations: FDA lab confirmed presence of an impurity, N-Methylnitrosobutyric acid (NMBA) in the finished product above the interim acceptable daily intake level.
- Published
- May 8, 2019
- Distribution
- Nationwide
View recall →
FDA Recall
Ongoing
Historical recordClass II
Losartan Potassium and Hydrochlorothiazide Tablets, USP, 50mg/12.5mg, a) 30-count (NDC: 13668-116-30), b) 90-count (NDC: 13668-116-90), c) 1000-count (NDC: 13668-116-10), per bottle, Rx only, Manufactured by: Torrent Pharmaceuticals LTD, Indrad-382 721, Dist. Mehsana India
by Torrent Pharma Inc.
- Reason
- CGMP Deviations: FDA lab confirmed presence of an impurity, N-Methylnitrosobutyric acid (NMBA) in the finished product above the interim acceptable daily intake level.
- Published
- May 8, 2019
- Distribution
- Nationwide
View recall →
FDA Recall
Ongoing
Historical recordClass II
Losartan Potassium Tablets, USP, 100 mg, a) 90-count (NDC: 13668-115-90), b)1000-count (NDC: 13668-115-10) per bottle, Rx only, Manufactured by: Torrent Pharmaceuticals LTD, Indrad-382 721, Dist. Mehsana India
by Torrent Pharma Inc.
- Reason
- CGMP Deviations: FDA lab confirmed presence of an impurity, N-Methylnitrosobutyric acid (NMBA) in the finished product above the interim acceptable daily intake level.
- Published
- May 8, 2019
- Distribution
- Nationwide
View recall →
FDA Recall
Ongoing
Historical recordClass II
Losartan Potassium Tablets, USP, 50 mg, a) 90-count (NDC: 13668-409-90), b)1000-count (NDC: 13668-409-10) per bottle, Rx only, Manufactured by: Torrent Pharmaceuticals LTD, Indrad-382 721, Dist. Mehsana India
by Torrent Pharma Inc.
- Reason
- CGMP Deviations: FDA lab confirmed presence of an impurity, N-Methylnitrosobutyric acid (NMBA) in the finished product above the interim acceptable daily intake level.
- Published
- May 8, 2019
- Distribution
- Nationwide
View recall →
FDA Recall
Ongoing
Historical recordClass II
Losartan Potassium Tablets, USP, 25 mg, a) 90-count (NDC: 13668-113-90), b)1000-count (NDC: 13668-113-10) per bottle, Rx only, Manufactured by: Torrent Pharmaceuticals LTD, Indrad-382 721, Dist. Mehsana India
by Torrent Pharma Inc.
- Reason
- CGMP Deviations: FDA lab confirmed presence of an impurity, N-Methylnitrosobutyric acid (NMBA) in the finished product above the interim acceptable daily intake level.
- Published
- May 8, 2019
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
TriMix MEDIUM (Papaverine HCL 21 mg/mL Phentolamine Mesylate 0.7 mg/mL Alprostadil 7 mcg/mL), 2 mL multidose MDV Inj. Compounded. Customceutical Compounding 4611 E. Shea Blvd. Bldg 3 180, Phoenix, AZ 85028 Ph. 480 516 0272
by Customceutical Compounding
- Reason
- Lack of assurance of sterility for injectables and solutions intended to be sterile.
- Published
- May 8, 2019
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Trimix HIGH (Papaverine HCl 30 mg/mL Phentolamine Mesylate 2 mg/mL Alprostadil 20 mcg/mL), 2 mL multidose vial MDV Inj. Compounded. Customceutical Compounding 4611 E. Shea Blvd. Bldg 3 180, Phoenix, AZ 85028 Ph. 480 516 0272
by Customceutical Compounding
- Reason
- Lack of assurance of sterility for injectables and solutions intended to be sterile.
- Published
- May 8, 2019
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Test PROCYP (TESTOSTERONE CYPIONATE 200MG/ML TESTOSTERONE PROPIONATE 20MG/ML), 5 ML MULTIDOSE VIAL INJ COMPOUNDED. Customceutical Compounding 4611 E. Shea Blvd. Bldg 3 180, Phoenix, AZ 85028 Ph. 480 516 0272
by Customceutical Compounding
- Reason
- Lack of assurance of sterility for injectables and solutions intended to be sterile.
- Published
- May 8, 2019
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Test D (TESTOSTERONE CYPIONATE 200MG/ML VITAMIN D3 5,000IU/ML), 5 ML MULTIDOSE VIAL COMPOUNDED. Customceutical Compounding 4611 E. Shea Blvd. Bldg 3 180, Phoenix, AZ 85028 Ph. 480 516 0272
by Customceutical Compounding
- Reason
- Lack of assurance of sterility for injectables and solutions intended to be sterile.
- Published
- May 8, 2019
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Test D (TESTOSTERONE CYPIONATE 200MG/ML VITAMIN D3 5,000IU/ML), 5 ML MULTIDOSE VIAL COMPOUNDED. Customceutical Compounding 4611 E. Shea Blvd. Bldg 3 180, Phoenix, AZ 85028 Ph. 480 516 0272
by Customceutical Compounding
- Reason
- Lack of assurance of sterility for injectables and solutions intended to be sterile.
- Published
- May 8, 2019
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Lipoplex (METHIONINE 25 MG/ML INOSITOL 50 MG/ML CHOLINE CHLORIDE 50 MG/ML HYDROXOCOBALAMIN 500 MC/ML DEXPANTHENOL 50 MG/ML PYRIDOXINE HCL 50 MG/ML), 10 ML MULTIDOSE VIAL INJ COMPOUNDED. Customceutical Compounding 4611 E. Shea Blvd. Bldg 3 180, Phoenix, AZ 85028 Ph. 480 516 0272
by Customceutical Compounding
- Reason
- Lack of assurance of sterility for injectables and solutions intended to be sterile.
- Published
- May 8, 2019
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
HCG (CHORIONIC GONADOTROPIN 1000 IU/ML PEP 25 mg/mL) inj 5 mL multidose vial compounded. Customceutical Compounding 4611 E. Shea Blvd. Bldg 3 180, Phoenix, AZ 85028 Ph. 480 516 0272
by Customceutical Compounding
- Reason
- Lack of assurance of sterility for injectables and solutions intended to be sterile.
- Published
- May 8, 2019
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Glutathione 200mg/mL inj. a) 10 ML and b) 12 ML MULTIDOSE VIAL MDV Compounded. Customceutical Compounding 4611 E. Shea Blvd. Bldg 3 180, Phoenix, AZ 85028 Ph. 480 516 0272
by Customceutical Compounding
- Reason
- Lack of assurance of sterility for injectables and solutions intended to be sterile.
- Published
- May 8, 2019
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
BPlex (METHYLCOBALAMIN 1000 MCG/ML PYRIDOXAL 5 PHOSPHATE 20MG/ML DEXPANTHENOL 250MG/ML), 10 ML MULTIDOSE VIAL MDV INJ COMPOUNDED. Customceutical Compounding 4611 E. Shea Blvd. Bldg 3 180, Phoenix, AZ 85028 Ph. 480 516 0272
by Customceutical Compounding
- Reason
- Lack of assurance of sterility for injectables and solutions intended to be sterile.
- Published
- May 8, 2019
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
BPlex (METHYLCOBALAMIN 1000 MCG/ML PYRIDOXAL 5 PHOSPHATE 20MG/ML DEXPANTHENOL 250MG/ML), 10 ML MULTIDOSE VIAL MDV INJ COMPOUNDED. Customceutical Compounding 4611 E. Shea Blvd. Bldg 3 180, Phoenix, AZ 85028 Ph. 480 516 0272
by Customceutical Compounding
- Reason
- Lack of assurance of sterility for injectables and solutions intended to be sterile.
- Published
- May 8, 2019
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
HYDROmorphone 20 mg/100 mL Injectable Solution, Hydromorphone HCl 20 mg 0.9% Sodium Chloride 100 mL, Sterile single use bag, Compounded Drug, Avella of Houston 9265 Kirby Dr., Houston, TX 77054 (877) 794-0404, NDC: 42852-221-10
by Advanced Pharma Inc.
- Reason
- Sub-potency
- Published
- May 8, 2019
- Distribution
- Nationwide
View recall →
FDA Recall
Ongoing
Historical recordClass II
Losartan Potassium Tablets USP 25 mg 50 tablets (5x10) Unit Dose Rx Only NDC 50268-516-15 Manufactured for: AvKARE Inc. Pulaski, TN 38478
by AVKARE Inc.
- Reason
- CGMP Deviations: FDA lab confirmed presence of an impurity, N-Methylnitrosobutyric acid (NMBA) in the finished product above the interim acceptable daily intake level of 0.96 parts per million.
- Published
- May 8, 2019
- Distribution
- Nationwide
View recall →
FDA Recall
Ongoing
Historical recordClass II
Losartan Potassium Tablets USP 50 mg 50 tablets (5x10) Unit Dose Rx Only NDC 50268-517-15 Manufactured for: AvKARE Inc. Pulaski, TN 38478
by AVKARE Inc.
- Reason
- CGMP Deviations: FDA lab confirmed presence of an impurity, N-Methylnitrosobutyric acid (NMBA) in the finished product above the interim acceptable daily intake level of 0.96 parts per million.
- Published
- May 8, 2019
- 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.
Read the full medical disclaimer.