Amneal Pharmaceuticals LLC is voluntarily recalling 13 lots of Lorazepam Oral Concentrate, USP 2mg/mL, to the Consumer level due to a defect in the dropper markings. The Lorazepam Oral Concentrate, USP 2mg/mL, product is packaged with a dosing dropper, supplied to Amneal by a third party.
As a precautionary measure, the distribution firms Leader Brand, Major Pharmaceuticals, and Rugby Laboratories are jointly issuing a nationwide voluntary recall of all lots within expiry of all liquid products manufactured by PharmaTech LLC at its FDA registered facility in Davie, Fla. due to possible product contamination.
International Laboratories, LLC is voluntarily recalling one (1) Lot of Pravastatin Sodium Tablets USP 40 mg packaged in bottles of 30 tablets, to the consumer level due to mislabeling. The product is labeled as Pravastatin Sodium Tablets USP 40 mg but contained Bupropion Hydrochloride XL 300 mg tablets.
rugby® laboratories of livonia, mi is voluntarily recalling all lots within the expiry of diocto liquid and diocto syrup, (docusate sodium solutions) manufactured by pharmatech, llc of davie, fl due to a risk of product contamination with burkholderia cepacia. if a product contains b. cepacia, its use could result in infections in patients with compromised immune systems and in patients with chronic lung conditions such as cystic fibrosis. some of these infections may be serious or even life-threatening in the at-risk patient population.
sacramento, california, man of steel is voluntarily recalling 175 lots of man of steel 1 and man of steel 2, 4000mg at the retail level. the products have been found to contained undeclared sildenafil.
icu medical, inc. is voluntarily recalling one lot of 0.9% sodium chloride injection, usp 1000 ml to the hospital/user level due to a confirmed customer complaint of particulate matter identified as stainless steel within a single flexible container.
apace packaging llc is voluntarily recalling one lot of cyclobenzaprine hcl tablet, usp 5 mg 50ct unit dose, ndc# 50268-190-15, lot number 16710 and one lot of amantadine hcl capsule, usp 100 mg 50ct unit dose ndc# 50268-069-15, lot number 16710 to the retail level. these products have been recalled due to a potential mislabeling. a small number of cartons containing cyclobenzaprine hcl tablets 5 mg ud blister cards may potentially be mislabeled as amantadine hcl capsules, usp 100 mg. the unit dose blisters inside the carton are correctly labeled as cyclobenzaprine hcl tablet, usp 5 mg.
cantrell drug company is voluntarily recalling all lots of unexpired sterile drug products to the hospital and user level due to lack of sterility assurance. the recalled products were distributed to health care facilities nationwide, except to the states of connecticut, hawaii, south carolina and vermont. to date, cantrell has not received any reports of adverse events.
charlotte, nc, ultra shop supplement is voluntarily recalling super panther 7k capsules, [1 count blister card lot#: ro846356 and 6 count bottle lot ro246852 within expiry], distributed by sx power co., brooklyn, ny, to the consumer level. fda analysis found samples of super panther 7k to be tainted with undeclared sildenafil and tadalafil, active ingredients in two fda-approved prescription drug products, also known as phosphodiesterate 5-inhibitors (pde-5), used to treat erectile dysfunction (ed).
lorida- andropharm is voluntarily recalling all lots of sten z and m1 alpha capsules to the consumer level because these products contain derivatives of anabolic steroids rendering them unapproved drugs for which safety and efficacy have not been established and therefore subject to recall.