FDA instructed to ensure removal of recalled medicines

– Ramsammy
MINISTER of Health, Dr. Leslie Ramsammy has instructed the Food and Drug Administration (FDA) to visit pharmacies and shops countrywide to ensure the removal of products that were recalled recently.

Mc Neil Consumer Health Care, Fort Wellington, PA, in consultation with the Food and Drug Administration (FDA) in the United States, made the voluntary recall of Children’s and Infant’s liquid of Tylenol, Tylenol Plus, Motrin, Zyrtec and Benadryl which are manufactured in that country.
A release from the Guyana Ministry said the medicines were also distributed in Canada, Dominican Republic, Dubai, Fiji, Guam, Guatemala, Jamaica, Puerto Rico, Panama, Trinidad and Tobago and Kuwait.
The release identified sources where the pharmaceuticals were available as Woodlands Hospital, Distribution Services Limited, Trading and Distribution Inc. and Best Buy Pharmacy.
In the statement, Ramsammy said apart from those sources, many shops and pharmacies around Guyana may have the products and they have been asked to remove them from shelves.
Additionally, the FDA has contacted Woodlands Hospital, Distribution Services Limited, Trading and Distribution Inc. and Best Buy Pharmacy for a list of where the products might have been distributed.
The Ministry statement said McNeil Consumer Health Care has initiated the recall because some of the products may not have met the required quality standard and may contain higher concentration of active ingredients than is specified, while others may contain inactive ingredients that do not meet the internal testing requirements.
The statement said, while the potential for serious medical problems is remote, it is advisable that consumers, as a precaution, desist from using the medicines.
The Ministry is also advising that a health care provider should be consulted if a child has recently taken any of the products and is experiencing unexpected symptoms.
The following is a list of the products which NDC numbers can be located on the label of the bottle above the brand name:

PRODUCTS
NDC Number
TYLENOL® INFANTS DROPS
CONCENT RATED TYLENOL® INFANTS DROPS 1 OZ GRAPE FLAVOR
50580 – 144 – 01
CONCENT RATED TYLENOL® INFANTS DROPS 0.5 OZ GRAPE FLAVOR*
50580 – 144 – 15
CONCENT RATED TYLENOL® INFANTS DROPS 1 OZ CHERRY DYE FREE
50580 – 167 – 01
CONCENT RATED TYLENOL® INFANTS DROPS 0.5 OZ CHERRY FLAVOR
50580 – 143 – 15
CONCENT RATED TYLENOL® INFANTS DROPS 1 OZ CHERRY FLAVOR
50580 – 143 – 30
CONCENT RATED TYLENOL® INFANTS DROPS 0.5 OZ GRAPE – HOSPITAL
50580 – 144 – 18
CONCENT RATED TYLENOL® INFANTS DROPS 0.25 OZ GRAPE – SAMPLE
50580 – 144 – 40
CHILDREN’S TYLENOL®SUSPENSIONS
CHILDREN’S TYLENOL®SUSPENSION 2 OZ CHERRY BLAST FLAOR
50580 – 123 – 02
CHILDREN’S TYLENOL®SUSPENSION 4 OZ CHERRY BLAST FLAOR
50580 – 123 – 04
CHILDREN’S TYLENOL® DYE – FREE SUSPENSION 4 OZ CHERRY FLAOR
50580 – 166 – 04
CHILDREN’S TYLENOL®SUSPENSION 4 OZ GRAPE SPLASH
50580 – 296 – 04
CHILDREN’S TYLENOL®SUSPENSION 4 OZ BUBBLEGUM FLAOR
50580 – 407 – 04
CHILDREN’S TYLENOL®SUSPENSION 4 OZ VERY BERRY STRAWBERRY FLAOR
50580 – 493 – 04
CHILDREN’S TYLENOL®SUSPENSION 1 OZ CHERRY BLAST FLAOR – SAMPLE
50580 – 123 – 01
CHILDREN’S TYLENOL®SUSPENSION 4 OZ CHERRY BLAST FLAOR – HOSPITAL
50580 – 123 – 03
CHILDREN’S TYLENOL® PLUS SUSPENSIONS
CHILDREN’S TYLENOL® PLUS SUSPENSION 4 OZ COUGH & SORE THROAT CHERRY FLAVOUR
50580 – 247 – 04
CHILDREN’S TYLENOL® PLUS SUSPENSION 4 OZ COUGH & RUNNY NOSE CHERRY FLAVOUR
50580 – 249 – 04
CHILDREN’S TYLENOL® PLUS DYE – FREE SUSPENSION 4 OZ COLD AND STUFFY NOSE GRAPE FLAVOUR
50580 – 253 – 04
CHILDREN’S TYLENOL® PLUS DYE – FREE SUSPENSION 4 OZ COLD & COUGH GRAPE FLAVOUR
50580 – 254 – 04
CHILDREN’S TYLENOL® PLUS DYE – FREE  SUSPENSION 4 OZ MULTI – SYMPTOM COLD GRAPE FLAVOUR
50580 – 255 – 04
CHILDREN’S TYLENOL® PLUS SUSPENSION 4 OZ FLU BUBBLEGUM FLAVOUR
50580 – 386 – 04
CHILDREN’S TYLENOL® PLUS SUSPENSION 4 OZ COLD GRAPE FLAVOUR
50580 – 387 – 04
CHILDREN’S TYLENOL® PLUS SUSPENSION 4 OZ COLD AND ALLERGY CHERRY BUBBLEGUM FLAVOUR
50580 – 390 – 04
CHILDREN’S TYLENOL® PLUS SUSPENSION 4 OZ MULTI – SYMPTOM COLD GRAPE FLAVOUR
50580 – 391 – 04
MOTRIN®INFANTS* DROPS
CONCENTRATED MOTRIN® INFANTS DROPS 1 OZ BERRY DYE FREE
50580 – 198 – 01
CONCENTRATED MOTRIN® INFANTS DROPS 0.5 OZ BERRY DYE FREE
50580 – 198 – 15
CONCENTRATED MOTRIN® INFANTS DROPS 0.5 OZ BERRY FLAVOUR
50580 – 100 – 15
CHILDREN’S MOTRIN®SUSPENSIONS
CHILDREN’S MOTRIN® SUSPENSION 4 OZ BERRY DYE FREE
50580 – 184 – 04
CHILDREN’S MOTRIN® SUSPENSION 2 OZ BERRY FLAVOR
50580 – 601 – 02
CHILDREN’S MOTRIN® SUSPENSION 4 OZ BERRY FLAVOR
50580 – 601 – 04
CHILDREN’S MOTRIN® SUSPENSION 4 OZ TROPICAL PUNCH FLAVOR
50580 – 215 – 04
CHILDREN’S MOTRIN® SUSPENSION 4 OZ GRAPE FLAVOR
50580 – 603 – 04
CHILDREN’S MOTRIN® SUSPENSION 4 OZ BUBBLEGUM FLAVOR
50580 – 604 – 04
CHILDREN’S MOTRIN® SUSPENSION 1 OZ GRAPE SAMPLE
50580 – 603 – 01
CHILDREN’S MOTRIN® SUSPENSION 1 OZ BUBBLEGUM SAMPLE
50580 – 604 – 01
CHILDREN’S MOTRIN® SUSPENSION 1 OZ BERRY SAMPLE
50580 – 601 – 01
CHILDREN’S MOTRIN® SUSPENSION 4 OZ BERRY HOSPITAL
50580 – 601 – 50
CHILDREN’S MOTRIN® COLD SUSPENSIONS
CHILDREN’S MOTRIN® COLD SUSPENSION4 OZ COLD BERRY FLAVOUR
50580 – 902 – 04
CHILDREN’S ZYRTEC® LIQUIDS IN BOTTLES
CHILDREN’S ZYRTEC® SUGAR – FREE DYE – FREE 4 OZ BUBBLEGUM SYRUP
50580 – 721 – 04
CHILDREN’S ZYRTEC® SUGAR – FREE DYE – FREE 4 OZ GRAPE SYRUP
50580 – 730 – 04
CHILDREN’S ZYRTEC® SUGAR – FREE DYE – FREE 0.5 OZ GRAPE
50580 – 730 – 15
CHILDREN’S ZYRTEC® SUGAR – FREE DYE – FREE 0.5 OZ BUBBLEGUM
50580 – 721 – 15
CHILDREN’S ZYRTEC® SUGAR – FREE DYE – FREE 2 X 4 OZ BUBBLEGUM / LIQUID
50580 – 721 – 08
CHILDREN’S BENADRYL® ALLERGY LIQUIDS IN BOTTLES
CHILDREN BENADRYL® ALLERGY4 OZ SUGAR – FREE DYE – FREE BUBBLEGUM FLAVOURED LIQUID
50580 – 535 – 04

The following is also to be noted:

* CONCENTRATED TYLENOL® INFANTS DROPS 0.5 OZ GRAPE FLAVOUR is also
included in Johnson’s ® Baby Relief Kit.

* CONCENTRATED MOTRIN® INFANTS DROPS 0.5 OZ BERRY FLAVOR is also
included in Johnson’s ® Baby Relief Kit

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