Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), is voluntarily recalling three lots of Activase® (alteplase) 100mg vials, that were co-packaged with Sterile Water for Injection, to the hospital level. The vials of Sterile Water for Injection, manufactured by Hospira Inc., a Pfizer company, and packaged with Activase 100 mg, may be cracked or chipped at the neck of the vial and leaking.
PharMEDium Services, LLC (PharMEDium) is voluntarily recalling all unexpired lots of Oxytocin compounded with Lactated Ringers and all unexpired lots of Oxytocin compounded with Lactated Ringers and Dextrose products that were produced between July 6, 2017 and August 29, 2017 to the hospital/user level. The recall is being issued based on laboratory test results indicating a lower than expected potency on certain lots of Oxytocin compounded with Lactated Ringers and Oxytocin Compounded with Lactated Ringers and Dextrose which would lead to a lower dose being administered.
Hospira, Inc., a Pfizer company, is voluntarily recalling one lot of Hydromorphone HCI Injection, USP, CII (2 mg/mL) 1mg/mL Vial and four lots of Levophed® (Norepinephrine Bitartrate Injection, USP), 4 mg/4 mL (1 mg/mL) Vial due to a potential lack of sterility assurance resulting from use of a damaged sterilizing filter for nitrogen used in the manufacturing process. To date, Hospira, Inc., a Pfizer company has not received any reports of adverse events related to this recall.
Hospira, Inc., a Pfizer company, is voluntarily recalling one lot of Vancomycin Hydrochloride for Injection, USP, 750 mg/vial (NDC 0409-6531-02) lot 632153A, to the hospital/retailer level. The recall was due to a confirmed customer report for the presence of particulate matter, confirmed as glass, within a single vial.
Mid Valley Pharmaceutical is recalling lot# 23221701 of Doctor Manzanilla Cough & Cold and lot# 23221701 of Doctor Manzanilla Allergy & Decongestant Relief syrup to the consumer level. The products may potentially be contaminated with the bacteria Burkholderia cepacia. Contaminated products with Burkholderia cepacia can potentially result in serious infections, may be life-threating in patients with compromised immune systems. To date, Mid Valley Pharmaceutical, LLC has not received any reports of adverse events related to this recall.
Lucky Mart Inc. is voluntarily recalling lots C14005, C16001 and C16002 of Piyanping Anti-Itch Lotion to the consumer level. The product was manufactured using the active pharmaceutical ingredient dexamethasone rather than hydrocortisone. Dexamethasone is not listed as an ingredient in the labeling.
centurion labs is voluntarily recalling, as a precautionary measure, 1 lot of ninjacof (lot# 200n1601) and 1 lot of ninjacof a (lot# 201na1601) manufactured by vilvet (dania beach, fl) and distributed by centurion labs to the retail level due to potential contamination with burkholderia cepacia. centurion was notified by the fda regarding the potential contamination as they discovered this product may have been manufactured in a pharmatech, fda registered facility, in davie, fl. that was found to have a product that contained b. cepacia.
bella pharmaceuticals is voluntarily recalling all lots of unexpired sterile drug products due to lack of sterility assurance. the recalled products were distributed to health care facilities nationwide.
vital rx, inc. d/b/a atlantic pharmacy and compounding is voluntarily recalling all lots of all compounded injectable prescription medications to the consumer level. the compounded injectable prescription medications have been found to lack sterility assurance. atlantic pharmacy and compounding became aware of this issue during an fda (food and drug administration) inspection of the pharmacy.
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.