Pfizer Inc. initiated a voluntary recall of two lots of Effexor XR 150mg capsules and one lot of Greenstone LLC-branded Venlafaxine HCL 150mg capsules. This action is being taken because a pharmacist reported that one bottle of Pfizer’s Effexor XR contained one capsule of Tikosyn 0.25mg (a medication used to treat irregular heartbeats), in addition to the Effexor XR capsules. Although Pfizer has not received any other such reports, three lots of these medications are being voluntary recalled as a precaution because they were packaged on the same line. The use of Tikosyn by an Effexor XR/Venlafaxine HCL patient, where the contraindications and drug-drug interactions with Tikosyn have not been considered by the prescribing physician, could cause serious adverse health consequences that could be fatal.

You should contact your physician or healthcare provider if you have experienced any problems that may be related to taking or using this particular Lot of medication. In addition, you may contact your pharmacy to find out if your prescription may have been in the lot number that was recalled (Pfizer Lot #V130142; V130140, which will both expire in Oct. 2015 and Greenstone Lot# V130014, which expires in Aug. 2015).

This notice is to inform you that on 10/17/13, the U.S. Food and Drug Administration (FDA) announced that the drug manufacturer Hospira, Inc. initiated a voluntary recall of one lot of 1% Lidocaine HCL Injection, 10mg/mL, 20mL Multiple-dose Fliptop Vial. This recall is being conducted as a precautionary measure. This action is due to one confirmed customer report of visible particulate, identified in the primary container, in the form of dark red/black particles. The particulate was identified as oxidized stainless steel. In general, injected particulate matter may result acutely in local inflammation, phlebitis, and/or low-level allergic response.

You should contact your physician or healthcare provider if you have experienced any problems that may be related to taking or using this medication. In addition, you may contact your pharmacy to find out if your prescription may have been in the lot number that was recalled (Lot 25-090-DK – the lot number may be followed by 01 or 02). This lot was distributed March 2013 through June 2013.

If you have any questions or concerns regarding the above information please contact the PrimeTime Health Plan Member Services at 330-363-7407 or 1-800-577-5084.

This notice is to inform you that on 10/17/13, the U.S. Food and Drug Administration (FDA) announced that the drug manufacturer Nephron Pharmaceuticals Corporation (NPC) initiated a voluntary recall of Albuterol Sulfate Inhalation Solution, 0.083% (in the 25 count packaging). NPC is asking consumers to discontinue use and dispose of any product they may have that is included in this recall. NPC performs aseptic process simulation as part of an internal process to assure product quality. NPC has received no reportable adverse drug events for any of the lots included in this recall. Nevertheless, NPC has decided to initiate this recall as a precautionary measure. You should contact your physician or healthcare provider if you have experienced any problems that may be related to taking or using this particular Lot of medication. In addition, you may contact your pharmacy to find out if your prescription may have been in the lot number that was recalled (Lot #A3A33A, A3A33B, A3A34A, A3A35A, A3A36A, A3A37A, A3A38A, A3A40A, A3A41A and A3A42A).

You should contact your physician or healthcare provider if you have experienced any problems that may be related to taking or using this medication. In addition, you may contact your pharmacy to find out if your prescription may have been in the lot number that was recalled (Lot 25-090-DK – the lot number may be followed by 01 or 02). This lot was distributed March 2013 through June 2013.

If you have any questions or concerns regarding the above information please contact the PrimeTime Health Plan Member Services at 330-363-7407 or 1-800-577-5084.

Metoclopramide Injection and Ondansetron Injection by Hospira: Recall - Glass Strand Particulates Caused By Glass Supplier

Hospira, Inc. announced it initiated a voluntary nationwide recall of one lot of Metoclopramide Injection, USP, 10 mg/2 mL (5 mg/mL) and two lots of Ondansetron Injection, USP, 4 mg/2 mL, (2 mg/mL). This action is due to a confirmed vial defect where glass particulate matter (glass strands) were identified as being affixed to the inside of the vial walls. There is potential for the glass particulates to dislodge into the solution. To date, Hospira has not received reports of any adverse events associated with this issue for these lots

BACKGROUND:

Metoclopramide Injection, USP, 10 mg/2 mL (5 mg/mL), NDC 0409-3414-01, Lot 28-104-DK (the lot number may be followed by a 01), is packaged in a 2 mL single-dose flip-top vial, with an expiration date of October 1, 2014. Ondansetron Injection, USP, 4 mg/2 mL (2 mg/mL), NDC 0409-4755-03, Lots 29-484-DK and 29-510-DK (the lot numbers may be followed by a 01) are packaged in a 2 mL single-dose flip-top vial, with an expiration date of May 1, 2015. Both products are packaged as 25 units per carton/100 units per case in glass flip-top vials. The affected lots were distributed nationwide between June 2013 and September 2013 to wholesalers/distributors, hospitals and pharmacies.

The administration of an injectable with the presence of foreign particulates may potentially result in local inflammation, thrombophlebitis, and/or low-level allergic response. Signs and symptoms could include redness, pain, swelling at the site, fever, shortness of breath, tachycardia, nausea, and vomiting. Additionally, the particulate contaminants could potentially act as an emboli and impede blood flow causing tissue/organ damage, especially in vulnerable patients such as those undergoing surgery, immunosuppressed individuals, infants, children and the elderly, as well as patients with micro or macrovascular disease, such as cardiac and renal disease, who may be more at risk since their vasculature, and end organs, are already compromised.

RECOMMENDATION:

Anyone with an existing inventory should stop use and distribution, quarantine the product immediately, and call Stericycle at 1-877-497-3125 between the hours of 8am to 5pm ET, Monday through Friday, to arrange for the return of the product. Replacement product from other lots is available.

Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:

• Complete and submit the report Online at www.fda.go/MedWatch/report.htm
• Call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178