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Showing 921–940 of 2521 results

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Pseudoephedrine Oral Solution (Torrent Pharma) – Bacterial Contamination Risk (2019)

cGMP Deviations: Potential product contamination with Burkholderia cepacia (B.cepacia) and Ralstonia pickettii (R. pickettii).

Class IIModerate

FDAMay 21, 2019Nationwide• Torrent Pharma Inc

Cyproheptadine Syrup (Torrent Pharma) – Bacterial Contamination Risk (2019)

cGMP Deviations: Potential product contamination with Burkholderia cepacia (B.cepacia) and Ralstonia pickettii (R. pickettii).

Class IIModerate

FDAMay 21, 2019Nationwide• Torrent Pharma Inc

Suja Organic Kombucha Ginger Lemon (Suja) – Glass Fragments (2019)

Firm has received complaints of finding pieces of glass in the products.

Class IIModerate

FDAMay 20, 2019CA, CO, FL +16 more• Suja Life LLC

Suja Organic Kombucha Mixed Berries (Suja) – Glass Fragments (2019)

Firm has received complaints of finding pieces of glass in the products.

Class IIModerate

FDAMay 20, 2019CA, CO, FL +16 more• Suja Life LLC

Blue Plate Olive Oil Mayonnaise (Reily) – Yeast Gas Formation (2019)

Yeast presence that resulted in gas formation causing bottles to bloat and release mayonnaise.

FDAMay 20, 2019AL, AR, CA +11 more• Reily Foods Co., Inc

Blue Plate Light Mayonnaise (Reily) – Yeast Gas Formation (2019)

Yeast presence that resulted in gas formation causing bottles to bloat and release mayonnaise.

FDAMay 20, 2019AL, AR, CA +11 more• Reily Foods Co., Inc

Suja Organic Kombucha Peach Ginger (Suja) – Glass Fragments (2019)

Firm has received complaints of finding pieces of glass in the products.

Class IIModerate

FDAMay 20, 2019CA, CO, FL +16 more• Suja Life LLC

Suja Organic Kombucha Variety Pack (Suja) – Glass Fragments (2019)

Firm has received complaints of finding pieces of glass in the products.

Class IIModerate

FDAMay 20, 2019CA, CO, FL +16 more• Suja Life LLC

Senna Syrup (Geritrex) – Odor and Taste Issue (2019)

Failed Impurities/Degradation Specifications: Atypical odor and unpleasant taste was reported

Class IIModerate

FDAMay 6, 2019Nationwide• Geritrex, LLC

HoliCare Metabolism Cleansing Tablets (Life Rising) – High Lead (2019)

High lead levels in products

FDAMay 2, 2019IN• Life Rising Corporation

Rocking Sleepers (Kids II) – safety risk (2019)

All models of Kids II Rocking Sleepers. A full list of the names and model numbers affected is below: Style Number Product Name 10081 Bright Starts Playtime To Bedtime Rocking Sleeper 10126 Rock & Dream Sleeper - Iggy 10127 Ingenuity Rock And Dream Sleeper Lucy 10148 Ingenuity Moonlight Rocking Sleeper Cuddle Giraffe 10178 Bright Starts Pretty In Pink Playtime To Bedtime Rocking Sleeper 10289 Ingenuity Smartrock Poweradapt Sleeper Cambridge 10292 Ingenuity Rock N' Soothe Sleeper Dayton 10320 Automatic Rock 'N Soothe Sleeper - Cuddle Lamb 10380 Ingenuity Moonlight Rocking Sleeper Cuddle Lion 10568 Ingenuity Soothing Light Rocking Sleeper Vesper 10729 Bright Starts Toucan Tango Rocking Sleeper 10872 Ingenuity Moonlight Rocking Sleeper Zoo Zoo Zebra 10888 DreamComfort Automatic Rocking Sleeper - Whitley 10890 DreamComfort Soothing Light Rocking Sleeper - Addington 11021 Bright Starts Rocking Sleeper Jungle Bursts 11022 Bright Starts Pretty In Pink Rocking Sleeper Jungle Blooms 11063 Rock n' Soothe Sleeper - Moxley 11164 Ingenuity Moonlight Rocking Sleeper Lullaby Lion 11171 Ingenuity Rock N' Soothe Sleeper SUNNY SNUGGLES 11357 Ingenuity Rock N' Soothe Sleeper DAYTON 11429 Ingenuity Dream Comfort Automatic Rocking Sleeper Braden 11714 DreamComfort Automatic Rocking Sleeper - Anders 11792 Automatic Rock 'n Soothe Sleeper - Nolan 11894 Bright Starts ROCKING SLEEPER - JUNGLE GARDEN 11895 Bright Starts ROCKING SLEEPER - EVENING SAFARI 11962 Automatic Rock 'n Soothe Sleeper - Flora the Unicorn 12115 Automatic Rock N Soothe Sleeper - Nolan - Display 60130 Taggies Snuggle Me Sleeper Nestling Vine 60131 Bright Starts Playtime To Bedtime Sleeper 60163 Bright Starts Pretty In Pink Playtime To Bedtime Sleeper 60327 Ingenuity Moonlight Rocking Sleeper Deluxe Emerson 60328 Disney Baby/Bright Starts Bows & Butterflies Sleeper Minnie Mouse 60331 Ingenuity Moonlight Rocking Sleeper Lullaby Lamb 60401 Bright Starts Playtime To Bedtime Sleeper Playful Pinwheels 60600 Ingenuity Moonlight Rocking Sleeper Deluxe Winslow 60635 Ingenuity Moonlight Rocking Sleeper Deluxe Seneca All cloth component parts of the models identified above

CPSCApr 26, 2019Nationwide

Antibacterial Foaming Hand Wash (Inopak Ltd) – Manufacturing Deviation (2019)

CGMP Deviations: hand sanitizers and soaps were not produced under current good manufacturing practices.

Class IIModerate

FDAApr 22, 2019Nationwide• Inopak Ltd

Antibacterial Hand Soap (Inopak Ltd) – Manufacturing Deviation (2019)

CGMP Deviations: hand sanitizers and soaps were not produced under current good manufacturing practices.

Class IIModerate

FDAApr 22, 2019Nationwide• Inopak Ltd

Wawa Iced Tea (Wawa Inc) – Undisclosed Issue (2019)

WAWA has initiated a recall of 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) because of mislabeling. The label reads does not list required phenylketonuria warning and ingredient listing does not list Aspartame.

FDAApr 12, 2019DE, PA• Wawa, Inc.

Rock 'n Play Sleeper – Safety Concerns (2019)

This recall involves all Rock 'n Play Sleepers.

CPSCApr 12, 2019Nationwide

Gentamicin 160 mg/1000 mL Sterile Water (Anderson) – sterility issue (2019)

Lack of sterility assurance.

Class IIModerate

FDAApr 2, 2019Nationwide• Anderson Compounding Pharmacy, Inc. DBA Anderson Compounding Pharmacy

Neomycin/Polymixin Bladder Solution (Anderson Compounding) – sterility concern (2019)

Lack of sterility assurance.

Class IIModerate

FDAApr 2, 2019Nationwide• Anderson Compounding Pharmacy, Inc. DBA Anderson Compounding Pharmacy

Infant Cheetah Fur Jackets (Pinghu Tianli) – choking risk (2019)

This recall involves a faux fur mid-weight jacket sold in infant sizes 12 to 24 months. The underside of the jacket's label contains the printed style number C2185125-CT or C218525. Amerex Group is printed on a label underneath the washing instructions label.

CPSCApr 2, 2019Nationwide• Pinghu Tianli Garment Co., LTD, of Jiaxing, China

Baby Rattle Socks (Midwest-CBK) – choking risk (2019)

This recall involves various styles of Midwest Gift brand Baby Rattle Socks - Perfect Pair. The socks are 100% cotton and have an animal or character sewn onto the toe of the socks, including a snowman, reindeer, whale, flamingo, tiger, or shark. The socks were sold in children's sizes 0 to 12 months

CPSCMar 28, 2019Nationwide

Infant Cough Syrup (Kingston Pharma) – microbial contamination (2019)

Microbial contamination with Bacillius circulans and Bacillus cereus / thuringiensis / mycoides.

Class IIModerate

FDAMar 20, 2019Nationwide• Kingston Pharma LLC

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