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Suprep unsafe, 483's, infestations
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<p>[QUOTE="Anonymous, post: 4209198"]Suprep Bowel Prep Kit (sodium sulfate, potassium sulfate and magnesium sulfate) Oral Solution, 17.5g/3.13g/1.6g per 6 ounces, Kit contains: 2 6-ounce bottles of liquid bowel prep, 1 16-ounce mixing container, 1 patient booklet, Rx Only, NDC: 52268-012-01. Recall # D-837-2012</p><p>CODE</p><p>Lot #: 2811015, Exp. 07/13 </p><p>RECALLING FIRM/MANUFACTURER</p><p>Braintree Laboratories, Inc., Braintree, MA, by letter on October 19, 2011. Firm initiated recall is ongoing. </p><p>REASON</p><p>Labeling: Correct Labeled Product Miscart/Mispack; Missing product labeling on white carton containing the kit contents. However, each kit carton is loaded with properly labeled Suprep oral solution bottles, patient instructions for use, package insert/medication guide and mixing container.</p><p>VOLUME OF PRODUCT IN COMMERCE</p><p>25,134 kit cartons</p><p>DISTRIBUTION</p><p>Nationwide[/QUOTE]</p><p><br /></p>
[QUOTE="Anonymous, post: 4209198"]Suprep Bowel Prep Kit (sodium sulfate, potassium sulfate and magnesium sulfate) Oral Solution, 17.5g/3.13g/1.6g per 6 ounces, Kit contains: 2 6-ounce bottles of liquid bowel prep, 1 16-ounce mixing container, 1 patient booklet, Rx Only, NDC: 52268-012-01. Recall # D-837-2012 CODE Lot #: 2811015, Exp. 07/13 RECALLING FIRM/MANUFACTURER Braintree Laboratories, Inc., Braintree, MA, by letter on October 19, 2011. Firm initiated recall is ongoing. REASON Labeling: Correct Labeled Product Miscart/Mispack; Missing product labeling on white carton containing the kit contents. However, each kit carton is loaded with properly labeled Suprep oral solution bottles, patient instructions for use, package insert/medication guide and mixing container. VOLUME OF PRODUCT IN COMMERCE 25,134 kit cartons DISTRIBUTION Nationwide[/QUOTE]
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Cafepharma Message Boards | Pharma Sales, Device Sales, Lab Sales
Home
Forums
>
Pharmaceutical Contract Manufacturing
>
Pharma Contract Manufacturing - General Discussion
>
Suprep unsafe, 483's, infestations
>
Cafepharma Message Boards | Pharma Sales, Device Sales, Lab Sales
Home
Forums
>
Pharmaceutical Contract Manufacturing
>
Pharma Contract Manufacturing - General Discussion
>
Suprep unsafe, 483's, infestations
>