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Product Recalls

November 6 – December 3, 2013

This section includes recalls from the Food and Drug Administration (FDA) Enforcement Report for drugs and dietary supplements (www.fda.gov/Safety/Recalls/EnforcementReports/default.htm), and Consumer Product Safety Commission (CPSC) recalls of consumer products.

DRUGS AND DIETARY SUPPLEMENTS

Recalls and Field Corrections: Drugs – Class II

Indicates a problem that may cause temporary or reversible health effects; unlikely to cause serious injury or death

Aldactone (Spironolactone) Tablets, USP, 100 mg, 100-count bottles. Lot #: V121573, expiration date 05/2017. Volume of product in commerce: 31 bottles. Marketed Without an Approved NDA/ANDA: This recall is being initiated because of changes to the dissolution profile in distributed lots resulting from a manufacturing site change. There is currently no approved application supporting the alternate manufacturing site. Pfizer Us Pharmaceutical Group.

Amlodipine Besylate Tablets, USP, 2.5 mg, packaged in a) 90-count bottles and b) 500-count bottles. Volume of product in commerce: 37,752 bottles. Lot #s: a) 3037907, 3040106; and b) 3037907, 3040106, 3044357. CGMP Deviations: Pharmaceuticals were produced and distributed with active ingredients not manufactured according to Good Manufacturing Practices. Mylan Pharmaceuticals Inc.

Amlodipine Besylate Tablets, USP, 5 mg, packaged in a) 90-count bottles and b) 500-count bottles. Volume of product in commerce: 167,866 bottles. Lot #s: 3036490, 3036491, 3036492, 3039874; b) 3036493, 3036494, 3039872, 3039873, 3041476, 3041477, 3044555, 3044683. CGMP Deviations: Pharmaceuticals were produced and distributed with active ingredients not manufactured according to Good Manufacturing Practices. Mylan Pharmaceuticals Inc.

Amlodipine Besylate Tablets, USP, 10 mg, packaged in a) 90-count bottles and b) 500-count bottles. Volume of product in commerce: 101,450 bottles. Lot #s: 3036490, 3036491, 3036492, 3039874; b) 3036493, 3036494, 3039872, 3039873, 3041476, 3041477, 3044555, 3044683. CGMP Deviations: Pharmaceuticals were produced and distributed with active ingredients not manufactured according to Good Manufacturing Practices. Mylan Pharmaceuticals Inc.

Amlodipine Besylate and Benazepril HCl Capsules, 5 mg/10 mg, packaged in a) 100-count bottles and b) 500-count bottles. Volume of product in commerce: 30,878 bottles. Lot #s: 2003159, 2003160, 2003161, 3043492, and b) 2003158, 2003159, 3043492. CGMP Deviations: Pharmaceuticals were produced and distributed with active ingredients not manufactured according to Good Manufacturing Practices. Mylan Pharmaceuticals Inc.

Amlodipine Besylate and Benazepril HCl Capsules, 5 mg/20 mg, packaged in a) 100-count bottles and b) 500-count bottles. Volume of product in commerce: 60,506 bottles. Lot #s: a) 2003169, 2003170, 2003171, 2003172, 2003173, 3043493; b) 2003168, 2003169, 3043493. CGMP Deviations: Pharmaceuticals were produced and distributed with active ingredients not manufactured according to Good Manufacturing Practices. Mylan Pharmaceuticals Inc.

Amlodipine Besylate and Benazepril HCl Capsules, 5 mg/40 mg, 100-count bottles. Volume of product in commerce: 11,701 bottles. Lot #s: 2003184, 2003185, 2003186, 3043495. CGMP Deviations: Pharmaceuticals were produced and distributed with active ingredients not manufactured according to Good Manufacturing Practices. Mylan Pharmaceuticals Inc.

Amlodipine Besylate and Benazepril HCl Capsules, 10 mg/20 mg, packaged in a) 100-count bottles and b) 500-count bottles. Volume of product in commerce: 42,174 bottles. Lot #s: a) 2003177, 2003178, 2003179, 2003180, 3043496; and b) 2003176, 2003177, 3043496. CGMP Deviations: Pharmaceuticals were produced and distributed with active ingredients not manufactured according to Good Manufacturing Practices. Mylan Pharmaceuticals Inc.

Amlodipine Besylate and Benazepril HCl Capsules, 10 mg/40 mg, 100-count bottles. Volume of product in commerce: 23,356 bottles. Lot #s: 2003188, 2003189, 2003190, 2003191, 3043498. CGMP Deviations: Pharmaceuticals were produced and distributed with active ingredients not manufactured according to Good Manufacturing Practices. Mylan Pharmaceuticals Inc.

Ciprofloxacin Tablets, USP, 250 mg, 100-count bottles. Volume of product in commerce: 521 bottles.  Lot #s: 3032075, 3032076. CGMP Deviations: Pharmaceuticals were produced and distributed with active ingredients not manufactured according to Good Manufacturing Practices. Mylan Pharmaceuticals Inc.

Ciprofloxacin Tablets, USP, 500 mg, 100-count bottles. Volume of product in commerce: 941,270 bottles. Multiple lots. Contact your pharmacist. CGMP Deviations: Pharmaceuticals were produced and distributed with active ingredients not manufactured according to Good Manufacturing Practices. Mylan Pharmaceuticals Inc.

Extended Phenytoin Sodium Capsules, USP, 100 mg, 1,000 capsules. Volume of product in commerce: 895 bottles. Lot #: HL50611, expiration date 1/2014. Failed Dissolution Specifications. Amneal Pharmaceuticals of New York, LLC.

Lamotrigine Tablets, USP, 200 mg, packaged in a) 60-count bottles and b) 500-count bottles. Volume of product in commerce: 28,140 bottles. Lot #s: a) 2003194, 2003195, and b) 2003193. CGMP Deviations: Pharmaceuticals were produced and distributed with active ingredients not manufactured according to Good Manufacturing Practices. Mylan Pharmaceuticals Inc.

Omeprazole Delayed-Release Capsules, USP, 20 mg. Volume of product in commerce: 3,867 bottles. Lot #: 59627, expiration date 02/2014. Failed Tablet/Capsule Specification: Some capsules over time do not meet or are suspected to not meet the specification for acid resistance. Kremers Urban Pharmaceuticals, Inc.

Ropinirole, Extended-Release Tablets, 2 mg, 90-count bottle. Volume of product in commerce: 692 bottles. Lot #: DJ2744, expiration date 12/2014. Cross Contamination with Other Products: Certain lots of ropinirole extended release tablets, 2 mg, have the potential presence of carryover coming from the previously manufactured product, mycophenolate mofetil. Sandoz, Inc.

Spironolactone Tablets, USP 25 mg, Rx only, 500-count bottle. Volume of product in commerce: 2,796 bottles. Lot #: V121207, V121208, expiration date 03/31/2017. Marketed Without an Approved NDA/ANDA: This recall is being initiated because of changes to the dissolution profile in distributed lots resulting from a manufacturing site change. There is currently no approved application supporting the alternate manufacturing site. Greenstone LLC.

Spironolactone Tablets, USP 50 mg, Rx only, 100-count bottle. Volume of product in commerce: 4,848 bottles. Lot #: V121211, expiration date 03/31/2017. Marketed Without an Approved NDA/ANDA: This recall is being initiated because of changes to the dissolution profile in distributed lots resulting from a manufacturing site change. There is currently no approved application supporting the alternate manufacturing site. Greenstone LLC.

CONSUMER PRODUCTS

Contact the Consumer Product Safety Commission (CPSC) for specific instructions or return the item to the place of purchase for a refund. For additional information from the CPSC, call its hotline at (800) 638-2772. The CPSC website is www.cpsc.gov. Visit www.recalls.gov for information about FDA recalls and recalls issued by other government agencies.

Name of Product; Problem; Recall Information

Angelcare Movement and Sound Baby Monitors. The cord attached to the baby monitor’s sensor pad is placed under the crib mattress, which poses a strangulation risk if the child pulls the cord into the crib and it becomes wrapped around the neck. Angelcare at (855) 355-2643 or http://www.angelcarebaby.com.

Avalanche Airbags. The trigger assembly can fail resulting in the airbag not deploying, posing a risk of death and injury in the event of an avalanche. Backcountry Access (BCA) at (800) 670-8735 or www.backcountryaccess.com.

Boy’s Hooded Jackets. The jackets have drawstrings in the hood around the neck area that pose a strangulation hazard to young children. In February 1996, CPSC issued guidelines about drawstrings in children's upper outerwear. In 1997, those guidelines were incorporated into a voluntary standard. Then, in July 2011, based on the guidelines and voluntary standard, CPSC issued a federal regulation. CPSC's actions demonstrate a commitment to help prevent children from strangling or getting entangled on neck and waist drawstrings in upper outerwear, such as jackets and sweatshirts. Vans Inc. at (800) 817-0618 or www.vans.com.

Boy’s Loungewear Pants. The pajama pants fail to meet federal flammability standards for children’s sleepwear, posing a risk of burn injuries to children. The Bailey Boys, Inc. at (855) 809-4400 or www.baileyboys.com.

Candelabra LED Bulbs. The bulbs can overheat and catch fire, posing a fire hazard. Infinity Green Products at (855) 376-3260 or www.infinitygreenproducts.com.

Ceiling Boxes. The ceiling box can crack causing the light fixture to fall from the ceiling, posing an impact hazard to consumers. Cooper Crouse-Hinds at (866) 764-5454 or www.crousehinds.com.

Children’s Nightgowns. The nightgowns fail to meet federal flammability standards for children’s sleepwear, posing a risk of burn injuries to children. Babycottons toll-free at (855) 922-2437 or www.babycottons.com.

Clay Bowl Outdoor Fireplaces. When fire is lit, pieces of the clay fireplace bowl can blow off of the bowl posing impact and burn hazards. Christmas Tree Shops at (888) 287-3232 or www.christmastreeshops.com.

Cuisinart 7-Cup Food Processors. The reversible slicing/shredding disc can loosen when in use and the blade can strike and break the food processor’s cover. The cover’s broken plastic pieces can hit consumers, posing a laceration hazard. Cuisinart at (877) 339-2534 or www.cuisinart.com.

ElliptiGO Outdoor Elliptical Cycles. The front fork on the ElliptiGO cycles can separate and the drive arm axles can detach during use, posing a fall hazard. ElliptiGO at (888) 551-0117 or www.elliptigo.com.

Gas-Fired Hot Water Boilers. The air pressure switch can fail to shut down the burners in the event that there is a blockage in the vent system allowing the boiler to emit excessive amounts of carbon monoxide, posing a CO poisoning hazard to the consumer. Crown Boiler Company at (855) 688-0776 or www.crownboiler.com.

Girl’s “Susan” Sandals. The top strap can be pulled loose from the shoe, posing a choking hazard to the child. American Boy and Girl at (800) 689-9237 or www.abgnyc.com.

Little Willy’s Hooded Sweatshirts. The hoodies have drawstrings through the hood or neck which pose a strangulation hazard to young children. In February 1996, CPSC issued guidelines about drawstrings in children's upper outerwear. In 1997, those guidelines were incorporated into a voluntary standard. Then, in July 2011, based on the guidelines and voluntary standard, CPSC issued a federal regulation. Little Willy’s at (212) 680-0107 or www.littlewillys.com.

L.L. Bean Girl’s Pajama Sets. The pajama sets fail to meet the federal flammability standard for children’s sleepwear, posing a risk of burn injuries to children. L.L. Bean at (800) 555-9717 or www.llbean.com.

Lullaby Cradle Glider. The mattress support board can fall out or slide out of the bottom of the cradle glider posing a risk that babies can fall out and suffer injuries. Dream On Me at (877) 201-4317 or www.dreamonme.com.

Mattresses and Mattresses with Foundations. The mattresses fail to meet the mandatory federal open flame standard for mattresses, posing a fire hazard to consumers. L&F International Trade at (301) 595-1062 or email LFinternationalinc@gmail.com.

Mini Bike. The front fork can separate from the wheel, posing fall and crash hazards to riders. Baja Inc., toll-free at (888) 863-2252 or www.bajamotorsports.com.

Precedent Golf and Transport Vehicles. Improper assembly can cause the front wheel spindles to crack causing the wheel to become loose affecting the steering, posing a crash hazard. Club Car at (800) 227-0739, ext. 3831, or www.clubcar.com.

Riley Duo Bunk Beds. The openings between the guardrails on the bunk bed can exceed 3 ½ inches in width, which is too wide and does not meet safety standards. This presents an entrapment hazard where a child could be seriously injured or become asphyxiated. Wood Castle Furniture at (571) 754-9304 or www.woodcastle.com.

Ryobi P113 Dual Chemistry Battery Chargers. The chargers can malfunction, posing fire and burn hazards to consumers. One World Technologies at (800) 597-9624 or www.ryobitools.com.

Step2® Whisper Ride Touring Wagon™. The removable blue seat backs can detach and allow the child in the wagon to fall out, posing a fall hazard. Contact Step2 at (866) 860-1887 or www.step2.com.

Tailwind Bicycle Racks for Trailercycles. The top portion of the tailwind rack that connects trailercycles to a towing bicycle can break and allow the trailercycle to disconnect, posing a fall hazard. Burley Design at (800) 311-5294 or www.burley.com.

Viking built-in side-by-side refrigerator freezers with in-door dispensers. Electrical connectors in the refrigerator freezer wiring harness can overheat, posing a fire hazard. Viking at (877) 266-1086 or www.vikingrange.com.

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