FDA Recall
Terminated
Historical recordClass III
Enalapril Maleate Tablets, USP, 2.5 mg, 100 Tablets (10 x 10) Unit Dose per carton, Rx only, Manufactured by: Wockhardt Limited, H-14/2, M.I.D.C. Area, Waluj, Aurangabad, Maharashtra, India; Distributed by: Wockhardt USA LLC., 20 Waterview Blvd., Parsippany, NJ 07054; Distributed by: MAJOR Pharmaceuticals, 17177 N Laurel Park Dr., Suite 233, Livonia, MI 48152; NDC 0904-5609-61.
by MAJOR PHARMACEUTICALS
- Reason
- Failed Impurities/Degradation Specifications: Sub-recall because this repackaged product was recalled by the manufacturing firm, Wockhardt, due to out-of-specification results for the Enalapril DiKetopiperazine degradation product.
- Published
- August 1, 2018
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Testosterone Cypionate Injection, USP, 200 mg/mL, Rx only, 10 mL vials, Distributed by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512, Manufactured by: Sun Pharmaceutical Industries, Ltd., Halol-Baroda Highway, Halol-389 350, Gujarat, India, NDC 62756-016-40
by Sun Pharmaceutical Industries, Inc.
- Reason
- Presence of Particulate Matter: organic and inorganic compounds detected in vials of product.
- Published
- August 1, 2018
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Unit Dose Valsartan Tablets, USP. 160 mg. Rx only.,Distributed by: Major Pharmaceuticals, Livonia, MI 48152, NDC# 0904-6594-61. NDC# 0904-6595-61.
by MAJOR PHARMACEUTICALS
- Reason
- CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
- Published
- August 1, 2018
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Unit Dose Valsartan Tablets, USP, 80 mg. Rx only, Distributed by: Major Pharmaceuticals, Livonia, MI 48152, NDC# 0904-6594-61.
by MAJOR PHARMACEUTICALS
- Reason
- CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
- Published
- August 1, 2018
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass III
Sisel International Llc
- Product
- Sisel, SiselRipt, postWORKOUT, Dietary supplement, net wt 5g…
- Reason
- Firm is recalling SiselRipt due to the presence of an unapproved artificial sweetener, Cyclamates.
- Published
- August 1, 2018
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
PHENYLephrine 10 mg (PHENYLephrine HCL (USP) 10mg, 0.9% Sodium Chloride (USP) 250 mL. Volume: 251 mL Single dose bag. For: Redlands Community Hospital Pharmacy. BY: Advanced Pharma, 9265 Kirby Dr., Houston, TX 77054 NDC 15082-856-25
by Avella of Deer Valley, Inc. Store 38
- Reason
- Lack of Assurance of Sterility: Potential leakage of bags.
- Published
- July 25, 2018
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
ePHEDrine Sulfate, USP 50 mg in 0.9% Sodium Chloride, USP QS 10mL. 50 mg/10 mL (5 mg per mL). Volume 10 mL Single dose syringe. Avella of Houston, 9265 Kirby Dr., Houston, TX 77054 NDC 42852-895-61
by Avella of Deer Valley, Inc. Store 38
- Reason
- Lack of Assurance of Sterility: Potential leakage of bags.
- Published
- July 25, 2018
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
ePHEDrine Sulfate, USP 25 mg in 0.9% Sodium Chloride, USP QS 5mL. Volume 5 mL Single dose syringe. Avella of Houston, 9265 Kirby Dr., Houston, TX 77054 NDC 42852-805-67
by Avella of Deer Valley, Inc. Store 38
- Reason
- Lack of Assurance of Sterility: Potential leakage of bags.
- Published
- July 25, 2018
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
PHENYLephrine 20 mg (PHENYLephrine HCL (USP) 20 mg, 5% Dextrose (USP) 250 mL) Volume: 252 mL. Single dose bag. For: Vidant Medical Center, By: Avella of Houston, 9265 Kirby Dr., Houston, TX 77054. NDC 42852-894-25
by Avella of Deer Valley, Inc. Store 38
- Reason
- Lack of Assurance of Sterility: Potential leakage of bags.
- Published
- July 25, 2018
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
NORepiNEPHrine4mg (Norepinephrine Bitartrate (USP) 4 mg added to 0.9% Sodium Chloride (USP) 250 mL Volume: 254 mL Single dose bag. Avella of Houston, 9265 Kirby Dr. Houston, TX 77054. NDC 42852-860-25
by Avella of Deer Valley, Inc. Store 38
- Reason
- Lack of Assurance of Sterility: Potential leakage of bags.
- Published
- July 25, 2018
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
NORepiNEPHrine4mg (Norepinephrine Bitartrate (USP) 4 mg added to 5% Dextrose Inj. (USP) 250 mL (Concentration 16 mcg/mL) Volume: 254 mL Single dose bag. Avella of Houston, 9265 Kirby Dr. Houston, TX 77054. NDC 42852-807-25
by Avella of Deer Valley, Inc. Store 38
- Reason
- Lack of Assurance of Sterility: Potential leakage of bags.
- Published
- July 25, 2018
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
NORepiNEPHrine Bitartrate, USP 160 mcg in 5% Dextrose, USP QS 10mL. Volume 10mL. Single dose syringe. Avella of Houston, 9265 Kirby Dr. Houston, TX 77054. NDC 42852-807-61
by Avella of Deer Valley, Inc. Store 38
- Reason
- Lack of Assurance of Sterility: Potential leakage of bags.
- Published
- July 25, 2018
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
NORepiNEPHrine 16 (NORepiNEPHrine Bitartrate (USP) 16 mg, 5% Dextrose Inj. (USP) 250 mL. Volume: 266 mL. Single dose bag. Avella of Houston, 9265 Kirby Dr. Houston, TX 77054. NDC 42852-834-25
by Avella of Deer Valley, Inc. Store 38
- Reason
- Lack of Assurance of Sterility: Potential leakage of bags.
- Published
- July 25, 2018
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Midazolam 1 mg/mL (Midazolam HCL (USP) 55 mg, 0.9% Sodium Chloride, (USP) QS 55 mL) Volume: 55mL. Single dose syringe. Advanced Pharma, 9265 Kirby Dr., Houston TX 77054. NDC 15082-401-76
by Avella of Deer Valley, Inc. Store 38
- Reason
- Lack of Assurance of Sterility: Potential leakage of bags.
- Published
- July 25, 2018
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Midazolam 0.5mg/mL (Midazolam HCL (USP) 50 mg, 0.9% Sodium Chloride, USP QS 100 mL) Volume: 100 mL. Single dose bag. For: Coral Gables Hospital, By: Advanced Pharma, 9265 Kirby Dr., Houston TX 77054. NDC 15082-408-10
by Avella of Deer Valley, Inc. Store 38
- Reason
- Lack of Assurance of Sterility: Potential leakage of bags.
- Published
- July 25, 2018
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Midazolam 1 mg/mL (Midazolam HCL USP 30 mg, 0.9% Sodium Chloride, USP QS 30 mL) Volume: 30 mL. Single dose syringe. For: Methodist Willowbrook Hospital, By: Advanced Pharma, 9265 Kirby Dr., Houston TX 77054. NDC 15082-401-63
by Avella of Deer Valley, Inc. Store 38
- Reason
- Lack of Assurance of Sterility: Potential leakage of bags.
- Published
- July 25, 2018
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
MORphine 150 mg (Morphine Sulfate, USP 150mg in 0.9% Sodium Chloride, USP QS 30mL). Volume 30 mL. Single dose syringe. Avella of Houston, 9265 Kirby Dr., Houston, TX 77054. NDC 42852-243-63
by Avella of Deer Valley, Inc. Store 38
- Reason
- Lack of Assurance of Sterility: Potential leakage of bags.
- Published
- July 25, 2018
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
MORphine 1 mg/mL (Morphine Sulfate, USP 250mg, 0.9% Sodium Chloride, USP 250 mL). Volume 255 mL. Single dose bag. Avella of Houston, 9265 Kirby Dr., Houston, TX 77054. NDC 42852-241-25
by Avella of Deer Valley, Inc. Store 38
- Reason
- Lack of Assurance of Sterility: Potential leakage of bags.
- Published
- July 25, 2018
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
MAGnesium 2gm in NS 100 mL (MAGnesium SULfate (USP) 2 gm, 0.9% Sodium Chloride (USP) 100 mL). Volume: 104 mL. Single dose bag. For: Desert Regional Med Ctr By: Avella of Houston, 9256 Kirby Dr., Houston, TX 77054. NDC: 42852-907-10
by Avella of Deer Valley, Inc. Store 38
- Reason
- Lack of Assurance of Sterility: Potential leakage of bags.
- Published
- July 25, 2018
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
MAGnesium 1gm in NS 100 mL (MAGnesium SULfate (USP) 1 gm, 0.9% Sodium Chloride (USP) 100 mL). Volume: 102 mL. Single dose bag. For: Salt Lake Regional Med Ctr By: Avella of Houston, 9256 Kirby Dr., Houston, TX 77054. NDC: 42852-906-10
by Avella of Deer Valley, Inc. Store 38
- Reason
- Lack of Assurance of Sterility: Potential leakage of bags.
- Published
- July 25, 2018
- 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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