All Recalls

Simply Fresh Fruit is recalling cantaloupe and fruit mixes with cantaloupe because they may be contaminated with Listeria monocytogenes.

Marketed without an approved NDA/ANDA: presence of undeclared sibutramine, desmethylsibutramine (an active metabolite of sibutramine) and phenolphthalein.

Lack of Assurance of Sterility: Potential cracks in glass vials

CGMP Deviations: potential contamination of products manufactured on the same equipment and lines as the contaminated product.

Marketed Without An Approved NDA/ANDA: The product contains undeclared sibutramine. The presence of sibutramine, a previously approved controlled substance that was removed from the U.S. market in October 2010 for safety reasons, in this tainted product renders it an unapproved drug for which safety and efficacy have not been established and therefore subject to recall.

Lack of Assurance of Sterility; sterility concerns with all injectable drug products that were made with sterilized filtered stock solutions.

Non Sterility; contaminated with Klebsiella pneumoniae

Failed Dissolution Specifications; 6 month time point

Labeling; Label Mixup; box labeled to contain 200 mg blister packs but actually contain 100 mg blister packs

Lack of Sterility Assurance

Defective delivery system: detached needles on the syringe in the kit.

Labeling: Label Mix Up- Incorrect back label applied to the product.

Microbial Contamination of Non-Sterile Products: contamination with the bacteria, Burkholderia cepacia.

Marketed without an approved NDA/ANDA - presence of undeclared sibutramine.

Failed Content Uniformity Specifications: resulting in both superpotent and subpotent tablets.

Failed Tablet/Capsule Specifications: Capsule shell (s) opening inside the bottle The Initial reports stated one or two capsules in a bottle count of 30s opening. First report came in June 14, 2016. Till date about 22 reports have come in from pharmacies which report two batches 130/16/001 and 130/16/002. Third batch 130/16/003 is not distributed yet, will be recalled from warehouse.

Marketed without an approved NDA/ANDA - presence of undeclared sibutramine.

Presence of particulate matter: Confirmed customer report for the presence of particulate matter within a single vial.

Lack of Assurance of Sterility; sterility concerns with all injectable drug products that were made with sterilized filtered stock solutions.

Failed Content Uniformity Specifications: resulting in both superpotent and subpotent tablets.