FDA Recall
TerminatedTerminated: May 23, 2017Historical recordClass II
BICARBONATE 10%, Rx only, Synergy RX, 4901 Morena Blvd # 504-A San Diego, CA 92117 (855) 792-6676
by Synergy Rx
- Reason
- Lack of Assurance of Sterility: There are also CGMP Deviations.
- Published
- March 22, 2017
- Distribution
- Nationwide
View recall →
FDA Recall
TerminatedTerminated: May 23, 2017Historical recordClass II
MINOXADIL all strength including 2%, 5% and MINOXIDIL / RETINOIC ACID 5% / 0.025, Synergy RX, 4901 Morena Blvd # 504-A San Diego, CA 92117 (855) 792-6676
by Synergy Rx
- Reason
- Lack of Assurance of Sterility: There are also CGMP Deviations.
- Published
- March 22, 2017
- Distribution
- Nationwide
View recall →
FDA Recall
TerminatedTerminated: May 23, 2017Historical recordClass II
5-FLUOROURACIL IN VANICREAM, FLUOROURACIL in all strengths including 0.05%, 5% CREAM, FLUOROURACIL 4.9% IN CERAVE CREAM, Synergy RX, 4901 Morena Blvd # 504-A San Diego, CA 92117 (855) 792-6676
by Synergy Rx
- Reason
- Lack of Assurance of Sterility: There are also CGMP Deviations.
- Published
- March 22, 2017
- Distribution
- Nationwide
View recall →
FDA Recall
TerminatedTerminated: May 23, 2017Historical recordClass II
TACROLIMUS 0.1% Ointment and TACROLIMUS 0.1%/KETOCONAZOLE 2%, Rx only, Synergy Rx, 4901 Morena Blvd #504-A San Diego, CA 92117 (855) 792-6676
by Synergy Rx
- Reason
- Lack of Assurance of Sterility: There are also CGMP Deviations.
- Published
- March 22, 2017
- Distribution
- Nationwide
View recall →
FDA Recall
TerminatedTerminated: May 23, 2017Historical recordClass II
KETOCONAZOLE 2%/HYDROCORTISONE 1.5% CREAM, Rx only, Synergy RX, 4901 Morena Blvd # 504-A San Diego, CA 92117 (855) 792-6676.
by Synergy Rx
- Reason
- Lack of Assurance of Sterility: There are also CGMP Deviations.
- Published
- March 22, 2017
- Distribution
- Nationwide
View recall →
FDA Recall
TerminatedTerminated: May 23, 2017Historical recordClass II
HCG and HCG with resveratrol Human Chorionic Gonadotropin in different strengths: HCG 300 UNITS/RESVERATROL 50MG S.L. Tablet, Rx only, Synergy RX, 4901 Morena Blvd # 504-A San Diego, CA 92117 (855) 792-6676
by Synergy Rx
- Reason
- Lack of Assurance of Sterility: There are also CGMP Deviations.
- Published
- March 22, 2017
- Distribution
- Nationwide
View recall →
FDA Recall
TerminatedTerminated: May 23, 2017Historical recordClass II
CANTHARADIN 0.7% SOLUTION and CANTHARIDAN / PODOPHYLLUM SOLUTION, CANTHARIDIN/PODOPHYLLUM RESIN MIXTURE, Rx only, Synergy RX, 4901 Morena Blvd # 504-A San Diego, CA 92117 (855) 792-6676
by Synergy Rx
- Reason
- Lack of Assurance of Sterility: There are also CGMP Deviations.
- Published
- March 22, 2017
- Distribution
- Nationwide
View recall →
FDA Recall
TerminatedTerminated: May 23, 2017Historical recordClass II
Human Chorionic Gonadotropin (HCG) 5,000 units/vial and 11,000 units/vial, Rx only, Synergy RX, 4901 Morena Blvd # 504-A San Diego, CA 92117 (855) 792-6676
by Synergy Rx
- Reason
- Lack of Assurance of Sterility: There are also CGMP Deviations.
- Published
- March 22, 2017
- Distribution
- Nationwide
View recall →
FDA Recall
TerminatedTerminated: June 13, 2017Historical recordClass III
PreviDent 5000 ppm, DRY MOUTH, 1.1% Sodium Fluoride, PRESCRIPTION STRENGTH TOOTHPASTE, SLS Free Formula, SOOTHING MINT, 3.4 FL OZ (100 mL), Colgate Oral Pharmaceuticals, Inc., New York, NY 10022 --- NDC 0126-0016-61, UPC 3834110622
by Colgate Palmolive Co
- Reason
- Label Mix up; rear panel is incorrectly labeled with the PreviDent 5000 Enamel Protect rear panel.
- Published
- March 22, 2017
- Distribution
- Nationwide
View recall →
FDA Recall
TerminatedTerminated: March 1, 2018Historical recordClass II
GlipiZIDE Extended-release tablets, 2.5 mg, 30-count carton (NDC 68084-295-21), Individual dose (NDC 68084-395-11), Rx Only, Packaged and Distributed by American Health Packaging, Columbus, Ohio 43217, NDC 68084-295-21
by Amerisource Health Services
- Reason
- Failed dissolution specifications: Glipizide 2.5 mg ER Tablets exceeded dissolution specification rates for the 10 hour testing point.
- Published
- March 22, 2017
- Distribution
- Nationwide
View recall →
FDA Recall
TerminatedTerminated: December 27, 2017Historical recordClass III
Clindamycin Phosphate Topical Solution USP, 1%, packaged in a) 30 mL applicator bottles (NDC 0472-0987-91) and b) 60 mL applicator bottles (NDC 0472-0987-92), Rx Only, Manufactured by: G&W Laboratories, Inc., 111 Coolidge Street, South Plainfield, NJ 07080; Distributed by: Actavis Mid Atlantic LLC, 1877 Kawai Road, Lincolnton, NC 28092.
by G & W Laboratories, Inc.
- Reason
- CGMP Deviations: an expired active ingredient was used in the manufacture of these recalled lots.
- Published
- March 22, 2017
- Distribution
- Nationwide
View recall →
FDA Recall
TerminatedTerminated: May 25, 2017Historical recordClass II
Triamcinolone 40 mg/mL 2 mL Single-Dose Vial for Injection, Preservative Free, Rx only, Compounded by Isomeric Pharmacy Solutions, Salt Lake City, UT 84109, NDC 70285-1920-1
by Isomeric Pharmacy Solution, LLC
- Reason
- CGMP Deviations
- Published
- March 22, 2017
- Distribution
- Nationwide
View recall →
FDA Recall
TerminatedTerminated: February 16, 2018Historical recordClass II
Buprenorphine and Naloxone Sublingual Tablets 8 mg/2 mg, 30 count HDPE bottles, Rx Only, Distributed by TEVA PHARMACEUTICALS USA, INC., North Wales, PA 19454, NDC 0093-5721-56
by Teva Pharmaceuticals USA
- Reason
- Failed Impurities/Degradation Specifications
- Published
- March 22, 2017
- Distribution
- Nationwide
View recall →
FDA Recall
TerminatedTerminated: June 22, 2018Historical recordClass III
PROTONIX I.V. (pantoprazole sodium) for Injection, Equivalent to 40 mg pantoprazole per vial, For I.V. infusion only, Rx Only, Distributed by Wyeth Pharmaceuticals Inc, A subsidiary of Pfizer Inc, Philadelphia, PA 19101, Under license from Takeda GmbH, D78467 Konstanz, Germany, MADE IN FRANCE; packaged in A) Pfizer Injectables, 1 vial per carton (NDC 0008-0923-51) in a) bundles of 10 unit cartons (NDC 0008-0923-55) and b) 25 x 40 mg Vials per carton (NDC 0008-0923-60); B) NOVAPLUS, 1 vial per carton (NDC 00008-0941-01) in 25 x 40 mg Vials per carton (NDC 0008-0941-03); and C) PREMIERPro Rx, 1 vial per carton (NDC 0008-4001-01) in a) bundles of 10 unit cartons (NDC 0008-4001-10) and b) 25 x 40 mg Vials per carton (NDC 0008-4001-25).
by Pfizer Inc.
- Reason
- Subpotent Drug: Out of Specification (OOS) for potency at the 6-month stability time point.
- Published
- March 22, 2017
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
TerminatedTerminated: February 4, 2020Historical recordClass I
Gel Spice Co, Inc.
- Product
- 1) Ground Tumeric item #73535 Net Wt 50 lbs Distributed by…
- Reason
- Ground Turmeric may contain excess levels of lead.
- Published
- March 22, 2017
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
TerminatedTerminated: June 6, 2017Historical recordClass II
Krispy Kreme Doughnut Corporation
- Product
- Krispy Kreme Chocolate Iced Sprinkle Theme, 6 count boxes (U…
- Reason
- Product may contain foreign matter, metal pieces.
- Published
- March 22, 2017
- Distribution
- DE, MD, NC and VA.
View recall →
FDA Recall
🇺🇸 United States
TerminatedTerminated: June 6, 2017Historical recordClass II
Krispy Kreme Doughnut Corporation
- Product
- Krispy Kreme Doughnuts Choc Iced Custard Filled, 2 count box…
- Reason
- Product may contain foreign matter, metal pieces.
- Published
- March 22, 2017
- Distribution
- DE, MD, NC and VA.
View recall →
FDA Recall
🇺🇸 United States
TerminatedTerminated: June 6, 2017Historical recordClass II
Krispy Kreme Doughnut Corporation
- Product
- Krispy Kreme Doughnuts Choc Iced Kreme Filled, 2 count boxes…
- Reason
- Product may contain foreign matter, metal pieces.
- Published
- March 22, 2017
- Distribution
- DE, MD, NC and VA.
View recall →
FDA Recall
🇺🇸 United States
TerminatedTerminated: June 6, 2017Historical recordClass II
Krispy Kreme Doughnut Corporation
- Product
- Krispy Kreme Doughnuts Choc Iced Glazed, 2 count boxes (UPC…
- Reason
- Product may contain foreign matter, metal pieces.
- Published
- March 22, 2017
- Distribution
- DE, MD, NC and VA.
View recall →
FDA Recall
🇺🇸 United States
TerminatedTerminated: March 30, 2017Historical recordClass III
Batch International Llc
- Product
- Assorted chocolate truffles, packaged in Kraft colored boxes…
- Reason
- The allergens such as soy, milk, almond, coconut, hazelnut, and/or wheat are declared on an insert label inside of the assorted boxes, and not declared on the exterior of the boxes.
- Published
- March 22, 2017
- Distribution
- distributed in AZ, CA, CO, IA, IL, MD, M…
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.