First Source Issues Allergy Alert for Undeclared Milk in Several Dark Chocolate Products Received from our Supplier GKI Foods LLC

Summary Company Announcement Date: October 30, 2017
FDA Publish Date: December 29, 2017
Product Type: Food & Beverages Allergens Food & Beverage Safety Reason for Announcement: Recall Reason Description Undeclared milk
Company Name: First Source Brand Name: Brand Name(s) Wegmans, Alpine Valley, Circle K and others
Product Description: Product Description Dark Chocolate Products
Company Announcement First Source of Tonawanda, NY, is voluntarily recalling various packaged goods, as well as Products sold in grocery store bulk bins. All these products contain undeclared Milk. People who have an allergy or sensitivity to Milk run the risk of serious or life-threatening allergic…

Slade Gorton Co. Inc. Issues Allergy Alert On Undeclared Milk

Summary Company Announcement Date: June 08, 2017
FDA Publish Date: June 12, 2017
Product Type: Food & Beverages Allergens Food & Beverage Safety Reason for Announcement: Recall Reason Description Undeclared Milk
Company Name: Slade Gorton Co. Inc. Brand Name: Brand Name(s) Gourmet Bay
Product Description: Product Description Breaded Tilapia: toasted crumb, honey mustard, citrus coconut
Company Announcement Slade Gorton, Boston, MA is recalling the following products because they may contain undeclared milk. People who have an allergy or severe sensitivity to milk run the risk of serious or life-threatening allergic reaction if they consume these products. Gourmet Bay Toasted…

VITA-JEC K1 (Phytonadione) Solution [Aspen Veterinary Resources]

CLINICAL PHARMACOLOGY: Vita-Jec® K1 aqueous colloidal solution of vitamin K1 for parenteral injection, possesses the same type and degree of activity as does naturally-occurring vitamin K, which is necessary for the production via the liver of active prothrombin (factor II), proconvertin (factor VII), plasma thromboplastin component (factor IX), and Stuart factor (factor X). The prothrombin test is sensitive to the levels of three of these four factors-II, VII, and X. Vitamin K is an essential cofactor for a microsomal enzyme that catalyzes the post-translational carboxylation of multiple, specific, peptide-bound glutamic acid residues in inactive hepatic precursors of factors II, VII, IX, and X. The resulting gamma-carboxy-glutamic acid residues convert the precursors into active coagulation factors that are…

SUNMARK ACID REDUCER (Ranitidine) Tablet, Coated [Strategic Sourcing Services LLC]

What you should know about Regular Strength Ranitidine Tablets, 75 mg Acid Reducer (Please read all of this information before taking Ranitidine Tablets, 75 mg. Save this leaflet for future reference.) What are Ranitidine Tablets, 75 mg? • Ranitidine Tablets, 75 mg contain 75 mg of ranitidine (as ranitidine hydrochloride, 84 mg), a medicine that doctors have prescribed more than 200 million times worldwide. Excellent Safety Record • Ranitidine Tablets, 75 mg have been used safely and effectively for years as an over-the-counter medication. • Ranitidine Tablets, 75 mg are sodium and sugar free. …

TRAMADOL HYDROCHLORIDE Tablet, Film Coated [Unichem Pharmaceuticals (USA), Inc.]

5.1 Addiction, Abuse and Misuse Tramadol hydrochloride tablet contains tramadol, a Schedule IV controlled substance. As an opioid, tramadol hydrochloride exposes users to the risks of addiction, abuse, and misuse [see Drug Abuse and Dependence (9)]. Although  the  risk  of  addiction  in  any  individual  is  unknown,  it  can  occur  in  patients appropriately prescribed tramadol hydrochloride. Addiction can occur at recommended dosages and if the drug is misused or abused. Assess each patient’s risk for opioid addiction, abuse, or misuse prior to prescribing tramadol hydrochloride, and monitor all patients receiving tramadol hydrochloride for the development of these behaviors and conditions. Risks are increased in patients with a personal or family history of substance abuse (including drug or alcohol abuse…

DailyMed Drug Label Updates for the last seven days (since Aug 22, 2019 EDT)

DailyMed Drug Label Updates for the last seven days (since Aug 22, 2019 EDT)
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Thu, 29 Aug 2019 14:48:13 EDT
Thu, 29 Aug 2019 14:48:13 EDT
SOOTHE CHILDRENS (Calcium Carbonate) Tablet, Chewable [Walgreen Company]
Updated Date: Thu, 22 Aug 2019 00:00:00 EDT
http://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=0235e083-5f3d-4bae-b14a-b12db623180c&version=7
Thu, 22 Aug 2019 00:00:00 EDT
http://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=0235e083-5f3d-4bae-b14a-b12db623180c&version=7

SUNMARK INFANTS PAIN AND FEVER (Acetaminophen) Suspension [Strategic Sourcing Services LLC]
Updated Date: Thu, 22 Aug 2019 00:00:00 EDT
http://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=04ef9755-612c-43f8-adc8-1d3b114f3fce&version=4
Thu, 22 Aug 2019 00:00:00 EDT
http://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=04ef9755-612c-43f8-adc8-1d3b114f3fce&version=4

TRAZODONE HYDROCHLORIDE Tablet [REMEDYREPACK INC.]
Updated Date: Thu, 22 Aug 2019 00:00:00 EDT
http://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=0545507a-5c11-4451-872a-d2f7f0aaecd4&version=4
Thu, 22 Aug…

Hail Merry Issues Voluntary Recall Due to Labeling Error

Summary Company Announcement Date: May 22, 2017
FDA Publish Date: May 24, 2017
Product Type: Food & Beverages Allergens Food & Beverage Safety Reason for Announcement: Recall Reason Description Undeclared Cashews
Company Name: Hail Merry Brand Name: Brand Name(s) Hail Merry
Product Description: Product Description Lemon Mini Miracle Tart Party Pack
Company Announcement Cashews Listed as Ingredient but Omitted from “Contains” Allergen Warning Statement Dallas – Hail Merry LLC, a plant-based snack food company, voluntarily recalls its Meyer Lemon Mini Miracle Tart Party Pack of 6 from the market due to a labeling error. The products contain cashews as…

HEALTH MART IBUPROFEN (Ibuprofen) Tablet, Chewable [Strategic Sourcing Services LLC]

Allergy alert: Ibuprofen may cause a severe allergic reaction, especially in people allergic to aspirin. Symptoms may include: • hives • facial swelling • asthma (wheezing) • shock • skin reddening • rash • blisters If an allergic reaction occurs, stop use and seek medical help right away. Stomach bleeding warning: This product contains an NSAID, which may cause severe stomach bleeding. The chance is higher if your child: • has had stomach ulcers or bleeding problems • takes a…

SUNMARK LUBRICATING PLUS (Carboxymethylcellulose Sodium) Solution/ Drops [Strategic Sourcing Services LLC]

To receive this label RSS feed Copy the URL below and paste it into your RSS Reader application. https://dailymed.nlm.nih.gov/dailymed/labelrss.cfm?setid=043ea5ed-be47-4824-94ee-9b6004f079f7 To receive all DailyMed Updates for the last seven days Copy the URL below and paste it into your RSS Reader application. https://dailymed.nlm.nih.gov/dailymed/rss.cfm What will I get with the DailyMed RSS feed? DailyMed will deliver notification of updates and additions to Drug Label information currently shown on this site through its RSS feed. DailyMed will deliver this notification to your desktop, Web browser, or e-mail depending on the RSS Reader you select to use. To view updated drug label links, paste the RSS feed address (URL) shown below into a RSS reader, or use a browser which supports RSS feeds, such…

TIKOSYN (Dofetilide) Capsule [Pfizer Laboratories Div Pfizer Inc]

TIKOSYN® (Tee’ ko sin)(dofetilide) Capsules Read the Medication Guide before you start taking TIKOSYN and each time you get a refill. This information does not take the place of talking with your doctor about your condition or treatment. What is the most important information I should know about TIKOSYN? TIKOSYN can cause serious side effects, including a type of abnormal heartbeat called Torsade de Pointes, which can lead to death. To establish the right dose of TIKOSYN, treatment with TIKOSYN must be started in a hospital where your heart rate and kidney function will be checked for the first 3 days of treatment. It is important that when you go home, you take the…