Safety Alerts and Recalls – MPR
FDA Recalls Herbal Meds Being Marketed for Various Diseases
Mon, 29 Jul 2019 18:30:58 +0000

In addition to being manufactured outside of the controls required by current Good Manufacturing Practices, these products are also being marketed for diseases without FDA approval.

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Boxed Warning Added to Tofacitinib Prescribing Information
Fri, 26 Jul 2019 16:01:59 +0000

The Food and Drug Administration (FDA) has approved changes to the prescribing information for tofacitinib to include new warnings, including a Boxed Warning, regarding an increased risk of blood clots and death associated with the 10mg twice daily regimen.  The update comes after a review of data from an ongoing safety clinical trial of tofacitinib…

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Certain Breast Implants, Tissue Expanders Recalled Due to Cancer Link
Wed, 24 Jul 2019 20:51:17 +0000

Allergan is recalling BIOCELL textured breast implants and tissue expanders due to the potential risk for breast implant-associated anaplastic large cell lymphoma (BIA-ALCL). The move to recall was based on an analysis of medical device reports submitted to the Food and Drug Administration (FDA) related to BIA-ALCL and BIA-ALCL-related deaths associated with these devices. “Once…

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Oral Contraceptive Recalled Due to Possibility of Reduced Efficacy
Wed, 24 Jul 2019 18:14:56 +0000

Jubilant Cadista Pharmaceuticals is recalling 1 lot of the combination oral contraceptive Drospirenone and Ethinyl Estradiol Tablets, USP, 3mg/0.02mg due to the possibility of decreased product efficacy.  According to the Company, the recall is being initiated because of out-of-specification dissolution test results at the 3-month stability time point. As a result, product efficacy may be…

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Recall: Vials Labeled as Kogenate FS Contain Another Hemophilia A Treatment
Mon, 22 Jul 2019 15:42:15 +0000

Bayer announced a voluntary recall of 2 lots of Kogenate FS antihemophilic factor (recombinant) 2000 IU vials that actually contain FVIII hemophilia A treatment, Jivi antihemophilic factor (recombinant) PEGylated-aucl 3000 IU. The recalled Kogenate FS products, distributed from February 5, 2019 to July 15, 2019 from Bayer’s distribution sites in Berkeley, CA and Shawnee, KS,…

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Recall Of Multiple Rx, OTC Ophthalmic Products Announced
Tue, 16 Jul 2019 16:08:41 +0000

Altaire Pharmaceuticals announced the voluntary recall of multiple ophthalmic prescription  and over-the-counter drug products sold by OCuSOFT. The specific products include: OCuSOFT Homatropine Hydrobromide Ophthalmic Solution 5%; NDC# 54799-431-05; Product Size: 5mL OCuSOFT Tetracaine Hydrochloride Ophthalmic Solution USP, 0.5%; NDC# 54799-502-15; Product Size: 15mL OCuSOFT Goniosoft Hypromellose 2.5% Ophthalmic Demulcent Solution; NDC# 54799-503-15; Product Size:…

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Several Ophthalmic Products Recalled Due to Possible Sterility Issues
Wed, 03 Jul 2019 14:57:03 +0000

Altaire Pharmaceuticals announced the voluntary recall of multiple ophthalmic prescription drug products.

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Hydromorphone Injection Recalled Due to Presence of Sulfite
Wed, 03 Jul 2019 13:28:51 +0000

While no adverse events have been reported to date, the use of this product could potentially cause serious adverse reactions.

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Phase 3 Study Evaluating Novel Therapy for Pancreatic Cancer Discontinued
Tue, 02 Jul 2019 21:35:55 +0000

Boston Biomedical has announced that the CanStem111P study investigating napabucasin in patients with metastatic pancreatic cancer will be discontinued due to futility.

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Fluorouracil Injection Recalled Due to Glass Particulate
Tue, 02 Jul 2019 16:28:37 +0000

Fresenius Kabi USA, LLC is voluntarily recalling 2 lots of Fluorouracil Injection, USP 5g/100mL (50mg/mL), 100mL fill in 100mL vials, due to the potential for glass particulate. The recalled products, distributed between December 6, 2018 and February 20, 2019, have the following NDC number, lot number, and expiration date: 63323-117-69, 6120341, 4/2020 63323-117-61, 6120420, 4/2020…

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