Product Recalls in 2017
4,951 recalls issued this year
280
CPSC
2,623
FDA Food
1,141
FDA Drug
907
NHTSA
FDA Drug
Class II
Terminated
Potassium PHOSphate in 5% Dextrose Injection, 15 mMol in 250 mL in 250 mL Intravia Bag Service, Rx Only. PharMEDium Services, LLC 12620 W. Airport Blvd #130 Sugar Land, TX 77478 800-523-7749 Service C
June 26, 2017
Pharmedium Services, LLC
N/A units
FDA Drug
Class II
Terminated
Potassium PHOSphate in 0.9% Sodium Chloride Injection, 7.5 mMol in 100 mL in 150 mL Intravia Bag, Rx Only, PharMEDium Services, LLC 12620 W. Airport Blvd #130 Sugar Land, TX 77478 800-523-7749 Service
June 26, 2017
Pharmedium Services, LLC
N/A units
FDA Drug
Class II
Terminated
Potassium PHOSphate in 0.9% Sodium Chloride Injection, 30 mMol in a) 250 mL in 250 mL Intravia Bag Service Code 2K5290 NDC# 61553-290-11, b) 500 mL in 500 mL Intravia Bag Service Code 2K5285 NDC# 6155
June 26, 2017
Pharmedium Services, LLC
N/A units
FDA Drug
Class II
Terminated
Potassium PHOSphate in 0.9% Sodium Chloride Injection 15 mMol in a) 100 mL in 150 mL Intravia Bag Service Code 2K5295 NDC# 61553-295-48; b) 150 mL in 150 mL Intravia Bag Service Code 2K5292 NDC# 61553
June 26, 2017
Pharmedium Services, LLC
N/A units
FDA Food
Class II
Terminated
Oatmeal, Oatmeal Raisin Cookie And Caramel Sea Salt, Ice Cream Sammich, packaged in 5 oz plastic bags. Shatto Milk Company, Osborn, MO.
June 26, 2017
Shatto Milk Co
126 bags units
FDA Drug
Class II
Terminated
Potassium PHOSphate in 0.9% Sodium Chloride Injection, 10 mMol in a) 100 mL in 150 mL Intravia Bag (NDC 61553-288-48) Service Code: 2K5288, and b) 250 mL in 250 mL Intravia Bag (NDC 61553-281-11) Serv
June 26, 2017
Pharmedium Services, LLC
N/A units
FDA Food
Class II
Terminated
Buzzzz Honey Butter, packaged in 8 oz plastic tubs. Plant # 29-685 Osborn, MO.
June 26, 2017
Shatto Milk Co
180 tubs units
FDA Food
Class II
Terminated
Sugary, Sugar Cookie And Strawberry Ice Cream Sammich, packaged in 4 oz plastic bags. Shatto Milk Company, Osborn, MO.
June 26, 2017
Shatto Milk Co
140 bags units
FDA Drug
Class II
Terminated
Latanoprost PF Solution, 0.005%, Ophthalmic Drops in Sterile 5ml Bottles, Compounded for a licensed professional or patient use, imprimisRx, Irvine, CA
June 23, 2017
ImprimisRx CA, Inc., dba ImprimisRx
19 bottles units
NHTSA
Ongoing
Incorrect Air Bag Deployment Calibration Settings
June 23, 2017
JAGUAR LAND ROVER NORTH AMERICA, LLC
4,926 units
FDA Drug
Class II
Terminated
Timolol-Latanoprost PF Solution (0.5-0.005)%, Ophthalmic Drops, Sterile 5ml Bottle, Compounded for a licensed professional or patient use, imprimisRx, Irvine, CA
June 23, 2017
ImprimisRx CA, Inc., dba ImprimisRx
16 bottles units
FDA Drug
Class II
Terminated
Curcumin Emulsion 10mg/ml Injection, Sterile 10 mL Multiple Dose Vial, For Slow IV Administration, Compounded for a licensed professional or patient use by ImprimisRx, Irvine, CA
June 23, 2017
ImprimisRx CA, Inc., dba ImprimisRx
2608 vials units
FDA Drug
Class II
Terminated
Timolol-Brimonidine-Dorzolamide-Latanoprost (0.5/0.15/2/0.005)% Ophthalmic Drops, Sterile 5ml Bottle, Compounded for a licensed professional or patient use, imprimisRx, Irvine, CA
June 23, 2017
ImprimisRx CA, Inc., dba ImprimisRx
2 bottles units
NHTSA
Ongoing
Parking Brake Actuators may Corrode
June 22, 2017
MAZDA NORTH AMERICAN OPERATIONS
227,814 units
NHTSA
Ongoing
Possible Transmission Hydraulic Fluid Leak
June 22, 2017
Aston Martin Lagonda of North America
6 units
NHTSA
Ongoing
Mirrors on the Closet Doors may Detach
June 22, 2017
PLEASURE-WAY INDUSTRIES LTD.
37 units
FDA Drug
Class II
Terminated
Potassium Phosphate (USP) QS 0.9% Sodium Chloride (USP) 250 mL 20 mmol in NS 250mL Bag, Advanced Pharma, 9265 Kirby Dr., Houston, TX 77054 (877) 794-0404. NDC15082-926-25
June 22, 2017
Advanced Pharma Inc.
72 units units
NHTSA
Ongoing
Loss of Front Brakes
June 22, 2017
Wilwood Engineering
15,000 units
FDA Drug
Class I
Terminated
MAN OF STEEL capsules, 3000mgs/grain, 1-count packets, Packaged for: One Drop Solutions, LLC, POB 231693, Sacramento, California 95823; [email protected]; www.manofsteelpills.com; UPC 1 0001001378 7.
June 22, 2017
Vitility
75 packets units
FDA Food
Class II
Terminated
SAMI'S BAKERY, Oatmeal Raisin Cookies, Net Wt. 7oz., Refer questions or comments to: Sami's Bakery., Tampa, FL.
June 22, 2017
Sami's Pita Bakery, Inc.
unknown units
FDA Food
Class II
Terminated
SAMI'S BAKERY, BAKLAVA WALNUT, Net Weight. 4oz (112g)., Refer questions or comments to: Sami's Bakery., Tampa, FL.
June 22, 2017
Sami's Pita Bakery, Inc.
unknown units
FDA Drug
Class III
Terminated
Paroxetine Extended-Release Tablets USP, 12.5 mg, 30 count bottle, Rx only, Manufactured for: Lupin Pharmaceuticals, Inc. Baltimore, Maryland, 21202, Manufactured by: Lupin Limited, Pithampur (M.P.) 4
June 22, 2017
Lupin Pharmaceuticals Inc.
12480 bottles units
FDA Drug
Class II
Terminated
Potassium Phosphate (USP) QS 0.9% Sodium Chloride (USP) 250 mL 30 mmol in NS 250mL Bag, Advanced Pharma, 9265 Kirby Dr., Houston, TX 77054 (877) 794-0404. NDC15082-924-25
June 22, 2017
Advanced Pharma Inc.
FDA Food
Class II
Terminated
SAMI'S BAKERY, Walnut Chocolate Chip Cookies, Net Wt. 7oz. (196g), Packed by: Sami's Pita Bakery Inc., Tampa, FL.
June 22, 2017
Sami's Pita Bakery, Inc.
unknown units
FDA Drug
Class II
Terminated
Potassium Phosphate (USP) QS 0.9% Sodium Chloride (USP) 250 mL 15 mmol in NS 250mL Bag, Advanced Pharma, 9265 Kirby Dr., Houston, TX 77054 (877) 794-0404. NDC15082-922-25
June 22, 2017
Advanced Pharma Inc.
FDA Drug
Class II
Terminated
QUELICIN (Succinylcholine Chloride) Injection, USP 20 mg/mL in a) 5 mL vial (NDC 15082-814-67), b) 7mL vial (NDC 15082-814-79), c) 10mL vial (NDC 15082-814-61), Repackaged by Advanced Pharm, 9265 Kirb
June 22, 2017
Advanced Pharma Inc.
2350 units units
FDA Food
Class II
Terminated
MCCAIN ONION RING BATTERED PORTION PERFECT ¿ 60X4 oz
June 22, 2017
McCain Foods Canada, Inc.
242 cases units
FDA Food
Class II
Terminated
SAMI'S BAKERY, Peanut Butter Cookies, Net Wt. 7oz. (196g), Packed by: Sami's Pita Bakery Inc., Tampa, FL.
June 22, 2017
Sami's Pita Bakery, Inc.
unknown units
FDA Food
Class II
Terminated
SAMI'S BAKERY, Date Almond Cookies, Net Wt. 7oz. (196g), Packed by: Sami's Pita Bakery Inc., Tampa, FL.
June 22, 2017
Sami's Pita Bakery, Inc.
unknown units
NHTSA
Ongoing
Possible Clutch Fluid Leak
June 22, 2017
Aston Martin The Americas
179 units
NHTSA
Ongoing
Possible Fuel Leak from the Fuel Filler Cap Area
June 21, 2017
KTM NORTH AMERICA, INC
1,029 units
FDA Food
Class II
Terminated
Red Chili Wild Plum Dipping Sauce NET WT 10 oz. packaged in a glass jar
June 21, 2017
Texas Plum Line
148 bottles units
FDA Food
Class II
Terminated
Cristina brand Egg Crackers (Galletas de Huevo), 4OZ, Clear plastic/film type bag, ready-to-eat, dry/ambient storage
June 21, 2017
Cracker King Corp.
5183 cases units
FDA Drug
Class II
Terminated
Potassium PHOSphate added to 250 mL 0.9% Sodium Chloride 15 mMol (22 mEq K+) Total Approximate Volume 255 mL, Rx only, SCA Pharmaceuticals, Little Rock, AR 72205, NDC 70004-0841-40
June 21, 2017
SCA Pharmaceuticals
660 bags units
FDA Food
Class II
Terminated
Wild Plum Apricot Bread 16 oz packaged in a glass jar
June 21, 2017
Texas Plum Line
708 units units
FDA Food
Class II
Terminated
Sugar Plum Cake 16 oz packaged in a glass jar
June 21, 2017
Texas Plum Line
169 units units
FDA Food
Class II
Terminated
Peanut Patties 2.5 oz. wrapped in cellophane
June 21, 2017
Texas Plum Line
8633 units units
FDA Food
Class II
Terminated
A Creamy Praline 2 oz. wrapped in cellophane
June 21, 2017
Texas Plum Line
1670 units units
NHTSA
Ongoing
Incorrect Federal Certification Label/FMVSS 567
June 21, 2017
KZRV, L.P.
553 units
FDA Drug
Class II
Terminated
Potassium PHOSphate added to 250 mL 0.9% Sodium Chloride 10 mMol (14.67 mEq K+) Total Approximate Volume 254 mL, Rx only, SCA Pharmaceuticals, Little Rock, AR 72205, NDC 70004-0840-40
June 21, 2017
SCA Pharmaceuticals
221 bags units
FDA Food
Class II
Terminated
Special Dark Chocolate Cake 16 oz packaged in a glass jar
June 21, 2017
Texas Plum Line
156 units units
FDA Food
Class II
Terminated
A Texas Praline 14 oz. wrapped in cellophane
June 21, 2017
Texas Plum Line
265 units units
FDA Drug
Class II
Terminated
Potassium PHOSphate added to 250 mL 0.9% Sodium Chloride 15 mMol (22 mEq K+) Total Approximate Volume 255 mL, Rx only, SCA Pharmaceuticals, Little Rock, AR 72205, NDC 70004-0841-32
June 21, 2017
SCA Pharmaceuticals
20 bags units
FDA Drug
Class II
Terminated
Potassium PHOSphate added to 0.9% Sodium Chloride 250 mL Bag 30 mMol (44 mEq K+) Total Approximate Volume 260 mL, Rx only, SCA Pharmaceuticals, Little Rock, AR 72205, NDC 70004-0843-40
June 21, 2017
SCA Pharmaceuticals
20 bags units
NHTSA
Ongoing
Loss of Drive from Incorrect Clutch Software
June 21, 2017
Aston Martin Lagonda of North America
315 units
FDA Food
Class I
Terminated
The Smokehouse of NY Smoked Norwegian Fish packaged as: 4oz & 8oz and whole sides
June 21, 2017
The Smokehouse of New York, LLC.
Unknown units
FDA Food
Class II
Terminated
Extra Large Seasoned/Battered Jo-Jo Wedges / 00148 (5 lb bags)
June 20, 2017
Penobscot McCrum LLC
336 cases units
FDA Food
Class II
Terminated
Medium Battered Jo-Jo Wedges / 00126 (5 lb bags)
June 20, 2017
Penobscot McCrum LLC
4897 cases units
FDA Food
Class II
Terminated
Battered Jo-Jo Wedges / 00047 (5 lb bags)
June 20, 2017
Penobscot McCrum LLC
31956 cases units
FDA Food
Class II
Terminated
Valero Baby Wedges with Crisp Coat UC Coating / 51049 (5 lb bags)
June 20, 2017
Penobscot McCrum LLC
5924 cases units