FDA Recall
Terminated
Historical recordClass III
Testosterone Cypionate Injection, USP, 2000 mg/10 mL, 1 mL Vial, Single-Dose, Rx only, Mfd. for: Wilshire Pharmaceuticals, Inc. Atlanta, GA 30328. NDC 52536-625-01
by Arbor Pharmaceuticals Inc.
- Reason
- Labeling:Label Mix-up: Shipper Carton labelled Testosterone Cypionate Injection, USP, 200mg/mL, 1 ml single-dose vials, found to contain shelf cartons labelled as Testosterone Cypionate Injection USP, 200mg/mL, 10 ml multi-dose vials which contain Testosterone Cypionate Injection USP, 200mg/mL,1mL single-does vials
- Published
- November 6, 2019
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass III
Gatifloxacin Ophthalmic Solution 0.5%, For Use in the Eyes Only, Rx Only, Sterile, 2.5 mL bottle, Manufactured by Alcon Laboratories, Inc. Fort Worth, Texas 76134 for Sandoz Inc. Princeton, NJ 08540, Product of India, NDC 61314-672-25.
by Sandoz Inc
- Reason
- Labeling: Incorrect or missing package insert.
- Published
- November 6, 2019
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass III
Neomycin and Polymyxin B Sulfates and Dexamethasone Ophthalmic Suspension, Rx Only, Sterile, 5 mL bottle, Manufactured by Alcon Laboratories, Inc. Fort Worth, Texas 76134 for Sandoz Inc. Princeton, NJ 08540, NDC 61314-630-06
by Sandoz Inc
- Reason
- Labeling: Incorrect or missing package insert.
- Published
- November 6, 2019
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass III
Bimatoprost Ophthalmic Solution 0.03%, Rx Only, For Topical Application to the Upper Eyelid, Sterile, a) 3 mL bottle NDC 0781-6206-93, b) 5 mL bottle NDC 0781-6206-75, Manufactured by Alcon Laboratories, Inc. Fort Worth, Texas 76134 for Sandoz Inc., Princeton, NJ 08540, Product of Argentina.
by Sandoz Inc
- Reason
- Labeling: Incorrect or missing package insert.
- Published
- November 6, 2019
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Lyophilized Human Chorionic Gonadotropin 5,500 USP Units For injection, Rx Only, Compounded by: Innoveix Addison, TX 75001 800-370-1910
by Innoveix Pharmaceuticals Inc
- Reason
- Lack of Sterility Assurance.
- Published
- November 6, 2019
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Estradiol Vaginal Inserts USP, 10 mcg, packaged in a) 8-count Vaginal Inserts (with disposable applicators) per carton (NDC 68462-711-71) and b) 18-count Vaginal Inserts (with disposable applicators) per carton (NDC 68462-711-88), Rx only, Manufactured by: Glenmark Pharmaceuticals Ltd., Colvale-Bardez, Goa 403 513, India; Manufactured for: Glenmark Pharmaceuticals Inc., Mahwah, NJ 07430.
by Glenmark Pharmaceuticals Inc., USA
- Reason
- Defective Delivery System: complaints for difficulty in pushing the plunger of the applicator.
- Published
- November 6, 2019
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Prasugrel Tablets 5 mg, 30-count bottles, Rx only, Manufactured for: Mylan Pharmaceuticals Inc. Morgantown, WV 26505 U.S.A, NDC 0378-5185-93
by Mylan Pharmaceuticals Inc.
- Reason
- Failed Dissolution Specification: Low out of specification dissolution results.
- Published
- November 6, 2019
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass III
PF-Succinylcholine Chloride Injection, USP 20 mg/mL (200 mg/10 mL), Rx Only, Single-Dose Container, 5 x 10 mL pre-filled syringes, Nephron 503B Outsourcing Facility 4500 12th St. Ext West Columbia, SC 29172, NDC 69374-919-10.
by Nephron Pharmaceuticals Corporation dba Nephron Sterile Compounding Center
- Reason
- Incorrect labeling: Incorrect or missing lot and/or exp date
- Published
- November 6, 2019
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass I
Rong Shing Trading NY Inc
- Product
- Glam Day Nougat Candy packaged in 6-ounce (170g) plastic pac…
- Reason
- Product may contain undeclared allergens, specifically milk and eggs.
- Published
- November 6, 2019
- Distribution
- Retailers in 17 states: CO, FL, GA, IL,…
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
New Seasons Market LLC
- Product
- Honey Cake, internal PLU code 203190, is a seasonal bakery p…
- Reason
- Honey Cake's sticker on the top of a package states "buttermilk and sour cream" but milk is not declared. The bottom scale label has the Contains statement but "MILK" is not declared.
- Published
- November 6, 2019
- Distribution
- distributed in Oregon and Washington
View recall →
FDA Recall
Terminated
Historical recordClass II
Povidone Iodine, 5% Ophthalmic Solution, 5 mL per droptainer, Repackaged by: Avella Specialty Pharmacy, 24416 N. 19th Ave., Phoenix, AZ 85085. NDC 42852-006-20
by Avella of Deer Valley, Inc. Store 38
- Reason
- Lack of sterility assurance.
- Published
- October 30, 2019
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
del Nido Cardioplegia Solution, 1000 mL, Single-Dose Container, Rx Only Nephron 503B Outsourcing Facility 4500 12th St. Extension West Columbia, SC 29172 NDC: 69374-984-10
by Nephron Pharmaceuticals Corporation dba Nephron Sterile Compounding Center
- Reason
- Lack of Assurance of Sterility; bags have potential to leak
- Published
- October 30, 2019
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Amino Acid Injection 50 g/1000 mL (50 mg/mL) 25 g L-Arginine HCl; 25 g L-Lysine HCl, Single Dose Container, Rx Only Nephron 503B outsourcing facility 4500 12th St. Extension West Columbia, SC 29172 NDC: 69374-988-10
by Nephron Pharmaceuticals Corporation dba Nephron Sterile Compounding Center
- Reason
- Lack of Assurance of Sterility; bags have potential to leak
- Published
- October 30, 2019
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
PF-Fentanyl Citrate 2 mcg/mL* & Ropivacaine HCl 0.1% in 0.9% Sodium Chloride Injection-200 mL Total Dose: (400 mcg/200 mg)/200 mL, Rx Only Nephron 503B Outsourcing Facility 4500 12th St. Extension West Columbia, SC 29172 NDC: 69374-526-20
by Nephron Pharmaceuticals Corporation dba Nephron Sterile Compounding Center
- Reason
- GMP Deviations: potential glass contamination
- Published
- October 30, 2019
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
PF-Fentanyl Citrate 2 mcg/mL* & Bupivacaine HCl 0.125% in 0.9% Sodium Chloride Injection-250 mL, Rx Only Total Dose: (500 mcg/312.5 mg)/250 mL, Nephron 503B Outsourcing Facility 4500 12th St. Extension West Columbia, SC 29172 NDC: 69374-530-25
by Nephron Pharmaceuticals Corporation dba Nephron Sterile Compounding Center
- Reason
- GMP Deviations: potential glass contamination
- Published
- October 30, 2019
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
PF-Fentanyl Citrate (2 mcg/mL)* & Bupivacaine HCl 0.0625 in 0.9% Sodium Chloride Injection-250 mL Total Dose: (500 mcg/156.3 mg)/250 mL, Rx Only, Nephron 503B Outsourcing Facility 4500 12th St. Extension West Columbia, SC 29172 NDC 69374-0525-25
by Nephron Pharmaceuticals Corporation dba Nephron Sterile Compounding Center
- Reason
- GMP Deviations: potential glass contamination
- Published
- October 30, 2019
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
Hall Global, LLC
- Product
- Sugar Mill Farms Focused Energy 25 mg Hemp Extract Berry Fla…
- Reason
- Yellow #6 is not declared on ingredient label. The label lists Green Coffee Beans as an ingredient, but Guarana Seeds were used instead. The label lists the flavor as berry boost , but orange flavor was used.
- Published
- October 30, 2019
- Distribution
- Contract Manufacturer sends products to…
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
Hall Global, LLC
- Product
- OXZGEN Performance 25 mg Hemp Derived CBD + Teacrine + BCAA…
- Reason
- Yellow #6 is not declared on ingredient label. Label claim for B2 is incorrect (contains 5 mg not 10 mg as stated).
- Published
- October 30, 2019
- Distribution
- Contract Manufacturer sends products to…
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass III
Threshold Enterprises Ltd
- Product
- Source Naturals Dietary Supplement Brain Charge Advanced…
- Reason
- Labeling error; incorrect supplement facts panel and label claims for two ingredients were lower than the product formulation.
- Published
- October 30, 2019
- Distribution
- U.S. distribution to the following: AL,…
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
Wismettac Asian Foods, INC
- Product
- Shirakiku Buckwheat Noodles Yamaimo Soba With Concentration…
- Reason
- Product label identifies bonito, but product dipping sauce actually contains skipjack tuna, yellowfin tuna, and bluefin tuna as well as does not state the general allergen name of fish.
- Published
- October 30, 2019
- Distribution
- U.S. distribution to the following: AK,…
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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