Product Recalls in 2019

4,851 recalls issued this year

241

CPSC

1,807

FDA Food

1,788

FDA Drug

1,015

NHTSA

NHTSA Ongoing

Fairing may Damage Wiring, causing Stall

April 15, 2019 TRIUMPH MOTORCYCLES (AMERICA) LTD 1,201 units
NHTSA Ongoing

Cylinder Retaining Pin May Detach from Trailer

April 15, 2019 FONTAINE TRAILER COMPANY 123 units
FDA Drug Class II Terminated

Volumex (Iodinated I 131 Albumin) Injection USP, 25 uCi per 1 mL syringe, Rx Only, Manufactured for Daxor Corp., NY, NY; By: Iso-Tex Diagnostics, Inc.; NDC 50914-7720-8.

April 15, 2019 Iso-Tex Diagnostics, Inc 54 1ml syringes units
CPSC Ongoing

H&M Recalls Children's Bathrobes Due to Violation of Flammability Standard (Recall Alert)

April 15, 2019 H&M Hennes & Mauritz L.P., of New York, N.Y. About 980 (in addition, about 60 were sold in Canada) units
FDA Food Class II Terminated

Ben & Jerry s Coconut Seven Layer Bar Bulk . The product is sold in a tub containing 2.4 gallons .

April 15, 2019 Unilever 18,638 (total) units
FDA Food Class II Terminated

Ben & Jerry s Chunky Monkey. The product is sold in a pint tub (473 mL).

April 15, 2019 Unilever 18,638 (total) units
FDA Food Class II Terminated

Great Value, Finely Shredded, Fiesta Blend Cheese, Shredded Monterey Jack, Cheddar, Queso Quesadilla and Asadero Cheeses, Net Wt 8 oz; packaged in plastic pouches, 12 per case;

April 14, 2019 Schreiber Foods Inc 20,862 cases units
FDA Food Class II Terminated

Shredded and blocks of Colby & Monterey Jack cheese - Labeled and Packaged: 1) Great Value, Finely Shredded, Colby & Monterey Jack Cheese, Net Wt 8 oz; packaged in plastic pouches, 12 per case; 2

April 14, 2019 Schreiber Foods Inc 64,549 cases units
FDA Food Class II Terminated

Chewy Chips Ahoy Cookie (13 OZ)

April 13, 2019 Mondelez Global Llc 59,768 Cases units
FDA Drug Class II Terminated

Lidocaine 1% - Sodium Bicarbonate 8.4% 1:1, 1 mL syringe, For Intradermal Use Only, Made by: Enterprise Pharmacy, 4400 Golf Acres Drive, Bldg. J Suite E, Charlotte, NC, 28208.

April 12, 2019 CMC Enterprise Pharmacy 1135 syringes units
FDA Drug Class II Terminated

Magnesium Sulfate 2 GM in NS 50 mL bag, Made by: Enterprise Pharmacy, 4400 Golf Acres Drive, Bldg. J Suite E, Charlotte, NC, 28208.

April 12, 2019 CMC Enterprise Pharmacy 6746 bags units
FDA Drug Class II Terminated

Chlorothiazide 100 mg, 3.57 mL syringe, Made by: Enterprise Pharmacy, 4400 Golf Acres Drive, Bldg. J Suite E, Charlotte, NC, 28208.

April 12, 2019 CMC Enterprise Pharmacy 60 syringes units
FDA Drug Class II Terminated

CeFAZolin 3 gm 100 mg/mL, 30 mL syringe, Made by: Enterprise Pharmacy, 4400 Golf Acres Drive, Bldg. J Suite E, Charlotte, NC, 28208.

April 12, 2019 CMC Enterprise Pharmacy 475 syringes units
FDA Food Class III Terminated

Wawa Iced Tea Less Sugar, Net weight/number of units per package: 12 FL OZ. , Package type: Bottle Units per case: 24, Expiration date: April 29, 2019 (APR/29/19)

April 12, 2019 Wawa, Inc. 710 cases were distributed. units
FDA Drug Class II Terminated

Norepinephrine 16 mg in NS 250 mL bag, Made by: Enterprise Pharmacy, 4400 Golf Acres Drive, Bldg. J Suite E, Charlotte, NC, 28208.

April 12, 2019 CMC Enterprise Pharmacy 2567 bags units
CPSC Ongoing

Fisher-Price Recalls Rock 'n Play Sleepers Due to Reports of Deaths

April 12, 2019 About 4.7 million products units
FDA Drug Class II Terminated

Clindamycin 900 mg in NS 50 mL bag, Made by: Enterprise Pharmacy, 4400 Golf Acres Drive, Bldg. J Suite E, Charlotte, NC, 28208.

April 12, 2019 CMC Enterprise Pharmacy 1233 bags units
FDA Food Class I Terminated

Fresh cut watermelon, fresh cut honeydew melon, fresh cut cantaloupe and fresh cut mixed fruit containing one of these melons.

April 12, 2019 Caito Foods LLC. 279,205 retail units units
FDA Food Class II Terminated

Colby Jack Cheese in 40 pound and 640 pound blocks

April 12, 2019 Hilmar Cheese Company, Inc. 203,928.98 lbs units
FDA Drug Class II Terminated

Phenylephrine 0.8 mg/10 mL NS (0.08 mg/mL), (80 mcg/mL) syringe, Made by: Enterprise Pharmacy, 4400 Golf Acres Drive, Bldg. J Suite E, Charlotte, NC, 28208.

April 12, 2019 CMC Enterprise Pharmacy 1310 syringes units
FDA Drug Class II Terminated

Vancomycin 1500 mg in NS 250 mL bag, Made by: Enterprise Pharmacy, 4400 Golf Acres Drive, Bldg. J Suite E, Charlotte, NC, 28208.

April 12, 2019 CMC Enterprise Pharmacy 715 bags units
FDA Drug Class II Terminated

Lidocaine Buffered with J-Tip 0.25 mL, 1 mL syringe, 10:1, For Intradermal Use Only, Made by: Enterprise Pharmacy, 4400 Golf Acres Drive, Bldg. J Suite E, Charlotte, NC, 28208.

April 12, 2019 CMC Enterprise Pharmacy 705 syringes units
FDA Drug Class II Terminated

Amoxicillin for Oral Suspension USP, 125 mg per 5 mL, packaged in (a) 150 mL bottle (NDC 0093-4150-80) (b) 80 mL bottle (NDC 0093-4150-79), Rx Only, Manufactured in Canada By: Teva Canada Limited Toro

April 12, 2019 Teva Pharmaceuticals USA 171,488 150 mL and 80 mL bottles units
FDA Drug Class II Terminated

Lidocaine 1% - Sodium Bicarb 8.4% 10:1, 10 mL syringe, For Intradermal Use Only, Made by: Enterprise Pharmacy, 4400 Golf Acres Drive, Bldg. J Suite E, Charlotte, NC, 28208.

April 12, 2019 CMC Enterprise Pharmacy 40 syringes units
FDA Drug Class II Terminated

Sodium Citrate 4%, 40 mg/mL, 3 mL syringe, Flush Syringe, Made by: Enterprise Pharmacy, 4400 Golf Acres Drive, Bldg. J Suite E, Charlotte, NC, 28208.

April 12, 2019 CMC Enterprise Pharmacy 40 syringes units
FDA Drug Class II Terminated

Dexmedetomidine 400 mcg in NS 100 mL bag, Made by: Enterprise Pharmacy, 4400 Golf Acres Drive, Bldg. J Suite E, Charlotte, NC, 28208.

April 12, 2019 CMC Enterprise Pharmacy 5678 bags units
FDA Drug Class II Terminated

CefTRIAXone 1 GM, 100 mg/mL, 10 mL syringe, Made by: Enterprise Pharmacy, 4400 Golf Acres Drive, Bldg. J Suite E, Charlotte, NC, 28208.

April 12, 2019 CMC Enterprise Pharmacy 15 syringes units
FDA Drug Class II Terminated

Oxytocin 30 units in NS 500 mL bag, Made by: Enterprise Pharmacy, 4400 Golf Acres Drive, Bldg. J Suite E, Charlotte, NC, 28208.

April 12, 2019 CMC Enterprise Pharmacy 3690 bags units
NHTSA Ongoing

Entry Steps May Break

April 12, 2019 SMC Trailers 92 units
NHTSA Ongoing

Loose Battery Terminal Connections

April 12, 2019 HONDA (AMERICAN HONDA MOTOR CO.) 50,504 units
FDA Drug Class II Terminated

CeFAZolin 2 GM a) in NS 100 mL bag; b) 100 mg/mL (20 mL) syringe, Made by: Enterprise Pharmacy, 4400 Golf Acres Drive, Bldg. J Suite E, Charlotte, NC, 28208.

April 12, 2019 CMC Enterprise Pharmacy a) 1357 bags; b) 6895 syringes units
FDA Drug Class II Terminated

Magnesium Sulfate 1 GM in NS 50 mL bag, Made by: Enterprise Pharmacy, 4400 Golf Acres Drive, Bldg. J Suite E, Charlotte, NC, 28208.

April 12, 2019 CMC Enterprise Pharmacy 2162 bags units
FDA Drug Class II Terminated

Magnesium Sulfate 6 GM in NS 50 mL bag, Made by: Enterprise Pharmacy, 4400 Golf Acres Drive, Bldg. J Suite E, Charlotte, NC, 28208.

April 12, 2019 CMC Enterprise Pharmacy 196 bags units
NHTSA Ongoing

Ignition Switch may Turn Off

April 12, 2019 SUBARU OF AMERICA, INC. 511 units
FDA Drug Class II Terminated

Magnesium Sulfate 4 GM in NS 50 mL bag, Made by: Enterprise Pharmacy, 4400 Golf Acres Drive, Bldg. J Suite E, Charlotte, NC, 28208.

April 12, 2019 CMC Enterprise Pharmacy 3007 bags units
FDA Drug Class II Terminated

Vancomycin 1250 mg in NS 250 mL bag, Made by: Enterprise Pharmacy, 4400 Golf Acres Drive, Bldg. J Suite E, Charlotte, NC, 28208.

April 12, 2019 CMC Enterprise Pharmacy 737 bags units
FDA Drug Class II Terminated

NICARdipine 25 mg in NS 250 mL EXCEL bag, Made by: Enterprise Pharmacy, 4400 Golf Acres Drive, Bldg. J Suite E, Charlotte, NC, 28208.

April 12, 2019 CMC Enterprise Pharmacy 1783 bags units
FDA Drug Class II Terminated

Vancomycin 1750 mg in 0.9% Sodium Chloride 500 mL bag, Made by: Enterprise Pharmacy, 4400 Golf Acres Drive, Bldg. J Suite E, Charlotte, NC, 28208.

April 12, 2019 CMC Enterprise Pharmacy 118 bags units
FDA Drug Class II Terminated

Phenylephrine 40 mg in 0.9% Sodium Chloride 250 mL bag, 160 mcg/mL, Made by: Enterprise Pharmacy, 4400 Golf Acres Drive, Bldg. J Suite E, Charlotte, NC, 28208.

April 12, 2019 CMC Enterprise Pharmacy 215 bags units
FDA Drug Class II Terminated

Sodium Bicarbonate 150 mEq in D5W 1000 mL bags, Made by: Enterprise Pharmacy, 4400 Golf Acres Drive, Bldg. J Suite E, Charlotte, NC, 28208.

April 12, 2019 CMC Enterprise Pharmacy 100 bags units
FDA Drug Class II Terminated

Vancomycin 1000 mg in NS 250 mL bag, Made by: Enterprise Pharmacy, 4400 Golf Acres Drive, Bldg. J Suite E, Charlotte, NC, 28208.

April 12, 2019 CMC Enterprise Pharmacy 532 bags units
FDA Drug Class II Terminated

CeFAZolin 1 GM a) in NS 100 mL bag; b) 100 mg/mL (10 mL) syringe, Made by: Enterprise Pharmacy, 4400 Golf Acres Drive, Bldg. J Suite E, Charlotte, NC, 28208.

April 12, 2019 CMC Enterprise Pharmacy a) 150 bags; b)1369 syringes units
NHTSA Ongoing

Side Curtain Air Bags may not Deploy/FMVSS 226

April 12, 2019 Karma Automotive LLC 231 units
FDA Drug Class II Terminated

Diltiazem 250 mg in NS 250 mL bag, Made by: Enterprise Pharmacy, 4400 Golf Acres Drive, Bldg. J Suite E, Charlotte, NC, 28208.

April 12, 2019 CMC Enterprise Pharmacy 1475 bags units
FDA Drug Class II Terminated

Phenylephrine 20 mg NS 250 mL bag, Made by: Enterprise Pharmacy, 4400 Golf Acres Drive, Bldg. J Suite E, Charlotte, NC, 28208.

April 12, 2019 CMC Enterprise Pharmacy 390 bags units
NHTSA Ongoing

Timing Belt Teeth May Separate

April 12, 2019 HONDA (AMERICAN HONDA MOTOR CO.) 93,946 units
FDA Drug Class II Terminated

DelNido Cardioplegia (Normosol-R pH 7.4 or Plasma-Lyte A pH 7.4 1000 mL bag) Mannitol 20%-16.3 mL, Potassium Chloride 2 meq/mL-13 mL, Sodium Bicarbonate 8.4%-Lidocaine 1%-1:1 Dilution-26 mL, Magnesium

April 12, 2019 CMC Enterprise Pharmacy 110 bags units
FDA Drug Class II Terminated

Vancomycin 2000 mg in 0.9% Sodium Chloride 500 mL bag, Made by: Enterprise Pharmacy, 4400 Golf Acres Drive, Bldg. J Suite E, Charlotte, NC, 28208.

April 12, 2019 CMC Enterprise Pharmacy 532 bags units
FDA Drug Class II Terminated

Alteplase 1 mg/mL 1 mL in 10 mL syringe, Made by: Enterprise Pharmacy, 4400 Golf Acres Drive, Bldg. J Suite E, Charlotte, NC, 28208.

April 12, 2019 CMC Enterprise Pharmacy 97 syringes units
FDA Drug Class II Terminated

Heparin Pork 30,000 Units in NS 1000 mL bag, Made by: Enterprise Pharmacy, 4400 Golf Acres Drive, Bldg. J Suite E, Charlotte, NC, 28208.

April 12, 2019 CMC Enterprise Pharmacy 87 bags units