Fagron Sterile Services is voluntarily recalling three (3) lots of Succinylcholine Chloride 20mg/mL 5mL syringe to the hospital/clinic level. The secondary recall of product manufactured by Hospira Inc., a Pfizer company, and repacked by Fagron Sterile Services is due to microbial growth detected during a routine simulation of Hospira’s manufacturing process, which represents the potential introduction of microorganisms into the product.
Advanced Pharma, Inc. d/b/a Avella of Houston (“Advanced Pharma”) is conducting a limited, voluntary recall due to Hospira Inc.’s (“Hospira”) June 15, 2017 recall announcement that microbial growth was detected during a routine simulation of the manufacturing process and therefore there was a lack of sterility assurance.
On June 10, Bristol-Myers Squibb announced a voluntary recall of one lot (#HN0063) of Eliquis 5 mg tablets. This lot was distributed nationwide in the U.S. to wholesalers and retail pharmacies in February 2017. Bristol-Myers Squibb is taking this precautionary measure based on a single customer complaint that a bottle labeled as Eliquis5 mg was found to contain Eliquis 2.5 mg tablets. No other lots are impacted by this recall.
Alvogen is voluntarily recalling seven lots of Clindamycin Injection USP ADD-Vantage Vials to the hospital/retail level due to microbial growth detected during a routine simulation of the manufacturing process, which represents the potential introduction of microorganisms into the product. Clindamycin Injection is manufactured for Alvogen by Hospira Inc., a Pfizer Company.
Hospira, Inc., a Pfizer company, is voluntarily recalling 42 lots of 8.4% Sodium Bicarbonate Injection, USP, 50 mL vials, 5 lots of NeutTM (Sodium Bicarbonate 4% additive solution) 5 mL vials, 5 lots of QUELICINTM (Succinylcholine Chloride Injection, USP) 200 mg/10 mL vials and 7 lots of Potassium Phosphates Injection, USP, 45 mM vials to the hospital/retail level due to microbial growth detected during a routine simulation of the manufacturing process, which represents the potential introduction of microorganisms into the products.
advanced pharma, inc. d/b/a avella of houston (“advanced pharma”) is voluntarily recalling all unexpired lots of nitroglycerin products that were produced at advanced pharma’s houston location between march 3, 2017 and may 31, 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 compounded nitroglycerin injection which would lead to a lower dose being administered.
teva pharmaceuticals usa, inc. (teva) initiated a voluntary recall to retail-level on 05/31/2017 for one lot of paliperidone extended-release tablets, 3mg, 90 count bottles that was distributed under the actavis pharma inc. label. in coordination with fda, teva is extending this recall to the consumer/user level.
phillips company is voluntarily recalling all lots of tetrastem, diabecline, tetracycline-abc, venomx, acneen, staphwash, stringmed, nopain and lidomed distributed by phillips company, with business offices located in sun city, arizona, to the retail level. the products are being recalled after an fda inspection found significant manufacturing practices that calls into question the safety, identity, strength, quality and purity of unexpired drug products made at the firm during the past three years.
bristol-myers squibb company (nyse: bmy) is voluntarily recalling one lot (#hn0063) of eliquis 5 mg tablets to the consumer level. this lot was distributed nationwide in the u.s. to wholesalers and retail pharmacies in february 2017. bristol-myers squibb is taking this precautionary measure based on a customer complaint that a bottle labeled as eliquis 5 mg was found to contain eliquis 2.5 mg tablets.
baltimore, maryland, lupin pharmaceuticals inc. announced today that it has voluntarily recalled lot l600518, exp 05/18 of mibelas 24 fe (norethindrone acetate and ethinyl estradiol 1 mg/0.02 mg chewable and ferrous fumarate 75 mg) tablets at the consumer level. a confirmed market complaint indicated a packaging error, where the blister was rotated 180 degrees within the wallet, reversing the weekly tablet orientation and making the lot number and expiration date no longer visible. the first four days of therapy would have had four non-hormonal placebo tablets as opposed to the active tablets.