FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
APS BioGroup, Inc
- Product
- Immuno PRP Spray, UPC 8 12527 01176 2. Colostrum Polypeptide…
- Reason
- The recall is being conducted as a result of elevated APC levels. Through additional testing, it was determined that the organism is Stenotrophomonas maltophilia.
- Published
- June 26, 2019
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
Gertrude Hawk Brands dba Gertrude Hawk Chocolates
- Product
- R.H. Macy & Co. Milk Chocolate Butter Almond Toffee, 6 oz.…
- Reason
- Products containing almonds and pecans were distributed in packaging that was mislabeled and did not reveal the presence of almonds and pecans.
- Published
- June 26, 2019
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
Gertrude Hawk Brands dba Gertrude Hawk Chocolates
- Product
- R.H. Macy & Co. Dark Chocolate Sea Salt Caramels, 7 oz. 1 u…
- Reason
- Products containing almonds and pecans were distributed in packaging that was mislabeled and did not reveal the presence of almonds and pecans.
- Published
- June 26, 2019
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
Gertrude Hawk Brands dba Gertrude Hawk Chocolates
- Product
- R.H. Macy & Co. Milk Chocolate Covered Pecan Caramel Cluster…
- Reason
- Products containing almonds and pecans were distributed in packaging that was mislabeled and did not reveal the presence of almonds and pecans.
- Published
- June 26, 2019
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
Gertrude Hawk Brands dba Gertrude Hawk Chocolates
- Product
- R.H. Macy & Co. Milk Chocolate Covered Peanut Butter Pretzel…
- Reason
- Products containing almonds and pecans were distributed in packaging that was mislabeled and did not reveal the presence of almonds and pecans.
- Published
- June 26, 2019
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Senna (sennosides 8.8 mg) Syrup 8 fl oz. (236 mL) bottles, Distributed by Geritrex, LLC 40 Commercial Avenue Middletown, NY 10941, NDC 54162-007-08
by Geritrex, LLC
- Reason
- Failed Impurities/Degradation Specifications: Atypical odor and unpleasant taste was reported
- Published
- June 19, 2019
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Senna (sennosides 8.8 mg) Syrup, 8 fl oz. (237 mL) bottles, Rij Pharmaceuticals Corporation 40 Commercial Avenue, Middletown, NY 10941, NDC 53807-556-08
by Geritrex, LLC
- Reason
- Failed Impurities/Degradation Specifications: Atypical odor and unpleasant taste was reported
- Published
- June 19, 2019
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Sevoflurane, USP Inhalation Anesthetic 250 mL bottles, Rx only, Manufactured for Baxter Healthcare Corporation Deerfield, IL 60015 USA, NDC 10019-651-64
by Baxter Healthcare Corporation
- Reason
- Failed Stability Specifications
- Published
- June 19, 2019
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Sn-Pyrophosphate Kit, 11.9 mg sodium pyrophosphate, Not for Direct Injection, Store at Room Temperature, Synthetopes, Inc.
by Synthetopes Inc
- Reason
- Lack of Processing Controls.
- Published
- June 19, 2019
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Sn-Tetrofosmin Kit 5.0 mL, Thaw and Vent before use, Not for Direct Injection, Store Frozen, Synthetopes, Inc.
by Synthetopes Inc
- Reason
- Lack of Processing Controls.
- Published
- June 19, 2019
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Sn-DTPA Kit 10 mg, DTPA, Not for Direct Injection, Store at Room Temperature, Synthetopes, Inc.
by Synthetopes Inc
- Reason
- Lack of Processing Controls.
- Published
- June 19, 2019
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Sn-d, l-Exametazime (Sn-d,l-HMPAO), Not for Direct Injection, Store Below 25 C, Synthetopes, Inc.
by Synthetopes Inc
- Reason
- Lack of Processing Controls.
- Published
- June 19, 2019
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Sulfur Colloid Reaction Vial 1.0 mL, Thaw Before Use, Not for Direct Injection, Store Frozen, Synthetopes, Inc.
by Synthetopes Inc
- Reason
- Lack of Processing Controls.
- Published
- June 19, 2019
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Sn-Mertiatide Kit,1 milligram betiatide, Not for Direct Injection, Store at Room Temperature, Synthetopes, Inc.
by Synthetopes Inc
- Reason
- Lack of Processing Controls.
- Published
- June 19, 2019
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Sn-DMSA solution, Store Frozen, Not for Direct Injection, Synthetopes, Inc.
by Synthetopes Inc
- Reason
- Lack of Processing Controls.
- Published
- June 19, 2019
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Pentreotide (10 uGm), Not for Direct Injection, Synthetopes, Inc.
by Synthetopes Inc
- Reason
- Lack of Processing Controls.
- Published
- June 19, 2019
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass I
AMIKACIN SULFATE INJECTION, USP, 1 gram/4 mL (250 mg/ml), 4 mL vial, Rx only, Mfd. by: Emcure Pharmaceuticals, Ltd., Hinjawadi, Pune, India Mfd. for: Heritage Pharmaceuticals Inc.. NDC 23155-290-32
by Heritage Pharmaceuticals, Inc.
- Reason
- Non-Sterility:Microbial growth detected in sub lot of Amikacin Sulfate Injection, USP 1gm/4 mL (250mg/mL) and Prochlorperazine Edisylate Injection, USP 10mg/2mL (5mg/mL) .
- Published
- June 19, 2019
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass I
PROCHLORPERAZINE EDISYLATE INJECTION, USP 10 mg/2mL (5mg/mL), 2mL Vial, Rx Only, Mfg by: Emcure Pharmaceuticals Ltd., Hinjawadi, Pune, India. Mfg for: Heritage Pharmaceuticals Inc. NDC 23155-294-31
by Heritage Pharmaceuticals, Inc.
- Reason
- Non-Sterility:Microbial growth detected in sub lot of Amikacin Sulfate Injection, USP 1gm/4 mL (250mg/mL) and Prochlorperazine Edisylate Injection, USP 10mg/2mL (5mg/mL) .
- Published
- June 19, 2019
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass III
Lotemax (loteprednol etabonate ophthalmic gel 0.5%), Sterile, Rx Only, 5 g box, Bausch & Lomb, a division of Valeant Pharmaceuticals North America LLC Bridgewater, NJ 08807 USA, NDC 24208-503-07.
by Bausch & Lomb
- Reason
- Failed Stability Specifications: Out of specification for viscosity.
- Published
- June 19, 2019
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass III
Ondansetron Injection, USP, 40 mg / 20 mL, 20 mL vial, Rx Only, Fresenius Kabi USA, LLC, Lake Zurich, IL 60047, NDC 63323-374-20
by Fresenius Kabi USA, LLC
- Reason
- Failed Impurities/Degradation Specifications.
- Published
- June 19, 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.
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