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FDA Consumer Health Information

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Medication Safety: Advice for New Moms

Mother's Day is May 14, and it's an exciting time for new moms. But moms and dads of babies 12 months and younger also can have some worries. If you're a new parent, or know one, see this advice on medication safety to help keep babies safe. 

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What to Know When Buying or Using a Breast Pump

Breast pumps are medical devices regulated by the U.S. Food and Drug Administration. But to protect mothers and their babies, there are important safety considerations to know before using one. Read the Consumer Update for answers to five key questions.

Publix Recalls Private Label Brand of Deli Artichoke and Spinach Dip Due to Possible Health Risk

05/09/2017 07:08 PM EDT

Publix Super Markets is issuing a voluntary recall for Publix Deli Artichoke and Spinach Dip due to the possibility of the product containing small glass fragments. The 16 oz. artichoke and spinach dip was sold at Publix stores in Florida, Georgia, South Carolina, North Carolina , Alabama and Tennessee with a UPC of 000-41415-15961, and a use-by-date of May 16 A1 and May 16 C1,which is printed on the lid of the container. The product in question is found in the refrigerated cases in the deli.

For detailed information pertaining to this Recalls, Market Withdrawals and Safety Alerts message, please click the link at the beginning of this bulletin.

Mikawaya Issues Allergy Alert On Undeclared Peanuts In Limited Quantity Of Mikawaya Chocolate Chocolate Mochi Ice Cream

05/10/2017 03:10 PM EDT

Mikawaya is issuing a voluntary recall of a limited number of Mikawaya Brand Chocolate Chocolate Mochi Ice Cream, which may inadvertently contain peanuts. People who have an allergy or severe sensitivity to peanuts run the risk of a serious or life-threatening allergic reaction if they consume the product. Only product labeled with UPC code of 070934990609 and lot number LOT 090-17 is included in this recall. The UPC code can be found on the back of the box and the lot number is printed on the top enclosure.

For detailed information pertaining to this Recalls, Market Withdrawals and Safety Alerts message, please click the link at the beginning of this bulletin.

Wegmans Food Markets Issues Allergy Alert On Undeclared Egg In Wegmans Family Pack Food You Feel Good About Net. Weight 48 ozs. (3 LB.) 1.36 KG Potato Salad

05/10/2017 02:38 PM EDT

A.S.K. Foods, Inc. of Palmyra, Pennsylvania is voluntarily recalling one lot of Wegmans Family Pack Food You Feel Good About Net Wt. 48 oz. (3 LB.) 1.46 KG Potato Salad because it may contain undeclared egg. People who have an allergy or severe sensitivity to egg run the risk of serious or life-threatening allergic reaction if they consume these products.

For detailed information pertaining to this Recalls, Market Withdrawals and Safety Alerts message, please click the link at the beginning of this bulletin.

What's New on the FDA Drugs Site

May 9, 2017
Spotlight on CDER Science: Modernizing the Way Drugs Are Made: A Transition to Continuous Manufacturing
C.O. Truxton, Inc. Issues Voluntary Nationwide Recall of Amitriptyline HCL Tablets, USP 50mg and Phenobarbital Tablets, USP 15mg, 30mg, 60mg, 100mg Due to Potential Label Mix-Up


Drug Approval Packages
Ocrevus (ocrelizumab) Injection
Drug Firm Annual Registration Status (updated)
Drug Firm Annual Registration Status Download File (updated)
Drug Trials Snapshots: RYDAPT
La FDA aprueba cambios en la etiqueta para el uso de anestésicos generales y sedantes en niños pequeños
National Drug Code Directory
Wholesale Distributor and Third-Party Logistics Providers Reporting(updated)

New and Generic Drug Approvals
May 9, 2017


Drug Name and
Application NumberActive IngredientDosage Form/ RouteSubmissionCompanySubmission ClassificationSubmission StatusBavencio
BLA #761078 Avelumab Injectable; Intravenous ORIG-1 Emd Serono Inc Type 1 - New Molecular Entity Approved

Showing 1 to 1 of 1 entries
May 8, 2017


Drug Name and
Application NumberActive IngredientDosage Form/ RouteSubmissionCompanySubmission ClassificationSubmission StatusArestin
NDA #050781 Minocycline Hydrochloride Powder, Extended Release; Dental SUPPL-20 Orapharma Labeling Approved
Bactroban
NDA #050591 Mupirocin Ointment; Topical SUPPL-34 Glaxosmithkline Labeling Approved
Bactroban
NDA #050703 Mupirocin Calcium Ointment; Nasal SUPPL-17 Glaxosmithkline Labeling Approved
Bactroban
NDA #050746 Mupirocin Calcium Cream; Topical SUPPL-21 Glaxosmithkline Labeling Approved
Epivir-Hbv
NDA #021003 Lamivudine Tablet; Oral SUPPL-16 Glaxosmithkline Labeling Approved
Epivir-Hbv
NDA #021004 Lamivudine Solution; Oral SUPPL-16 Glaxosmithkline Labeling Approved
Indomethacin
ANDA #204853 Indomethacin Capsule, Extended Release; Oral ORIG-1 Novast Labs Ltd Approved
Minolira
NDA #209269 Minocycline Hydrochloride Tablet, Extended Release; Oral ORIG-1 Dr Reddys Labs Ltd Type 5 - New Formulation or New Manufacturer Approved
Norgestrel and Ethinyl Estradiol
ANDA #202875 Ethinyl Estradiol; Norgestrel Tablet; Oral-28 ORIG-1 Mylan Labs Ltd Approved
Novolog Mix 70/30 Flexpen
NDA #021172 Insulin Aspart Protamine Recombinant; Insulin Aspart Recombinant Injectable; Subcutaneous SUPPL-62 Novo Nordisk Inc Labeling Approved
Novolog Mix 70/30
NDA #021172 Insulin Aspart Protamine Recombinant; Insulin Aspart Recombinant Injectable; Subcutaneous SUPPL-62 Novo Nordisk Inc Labeling Approved
Novolog Mix 70/30 Penfill
NDA #021172 Insulin Aspart Protamine Recombinant; Insulin Aspart Recombinant Injectable; Subcutaneous SUPPL-62 Novo Nordisk Inc Labeling Approved
Purixan
NDA #205919 Mercaptopurine Suspension; Oral SUPPL-2 Nova Labs Ltd Labeling Approved
Purixan
NDA #205919 Mercaptopurine Suspension; Oral SUPPL-2 Nova Labs Ltd Labeling Approved
Purixan
NDA #205919 Mercaptopurine Suspension; Oral SUPPL-2 Nova Labs Ltd Labeling Approved
Saizen
NDA #019764 Somatropin Recombinant Injectable; Injection SUPPL-86 Emd Serono Labeling Approved
Saizen
NDA #019764 Somatropin Recombinant Injectable; Injection SUPPL-86 Emd Serono Labeling Approved
Sodium Phenylacetate and Sodium Benzoate
ANDA #208521 Sodium Benzoate; Sodium Phenylacetate Solution; Iv (Infusion) ORIG-1 Maia Pharms Inc 

Quality Nut Co. Issues a Voluntary Recall

05/09/2017 07:09 PM EDT

Quality Nut Co. of Massillon, Ohio is voluntarily recalling the following products due to undeclared allergens:

For detailed information pertaining to this Recalls, Market Withdrawals and Safety Alerts message, please click the link at the beginning of this bulletin.

Fourth Street Barbecue/Packing Division Recalls Save-A-Lot Pick 5 Mix & Match Chicken & Waffle Sandwich Because Of Possible Health Risk

05/09/2017 07:07 PM EDT

Fourth Street Barbecue Inc. Packing Division has initiated a voluntary recall of all lot numbers of the Save-A-Lot Pick 5 Chicken Waffle Sandwich distributed nationwide as it has the potential to be contaminated with Listeria monocytogenes, an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems. Although healthy individuals may suffer only short-term symptoms such as high fever, severe headache, stiffness, nausea, abdominal pain and diarrhea, Listeria infection can cause miscarriages and stillbirths among pregnant women.

For detailed information pertaining to this Recalls, Market Withdrawals and Safety Alerts message, please click the link at the beginning of this bulletin.