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IMPORTANT - YOUR REPORT IS QUEUED - IT MAY TAKE UP TO 12 HOURS FOR YOUR REPORT TO SHOW ON OUR HOME PAGE (IF NOT OPTED AS PRIVATE)

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First dose of Pfizer Covid-19 Vaccine, Torrance, CA, USA

February 18, 2021 6:39 PM

Torrance, California, United States

Symptoms: Soreness

Went to the Forum for first dose on February 5. The people working there were friendly and got everyone through the process fairly quickly. I did not have a reaction other than a sore arm for a day or two. Due for second dose next week. I'm a 66 year old female.

Reported By SafelyHQ.com User

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“Company name: Meitheal Pharmaceuticals, Inc.
Brand name: Meitheal Pharmaceuticals, Inc.
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To date, Meitheal has not received reports of any adverse events or identifiable safety concerns attributed to the lot. There is a reasonable probability that a patient who requires cisatracurium for muscle paralysis as part of general anesthesia is administered phenylephrine instead would not receive any skeletal muscle relaxation and could cause a hyperadrenergic state resolution in elevated blood pressure, arrhythmia and cardiac/brain ischemia.  If this is not quickly diagnosed and treated, severe illness or death can occur. 

There is a reasonable probability that a patient who requires phenylephrine to increase their blood pressure, such as patients with severely low blood pressure, especially resulting from septic shock who is administered cisatracurium instead could result in a fast onset of muscle paralysis and decrease in oxygen. If this is not quickly diagnosed and treated, severe illness or death can occur within minutes. Cisatracurium Besylate Injection is used as a nondepolarizing neuromuscular blocker. 

The affected Cisatracurium Besylate Injection lot being recalled is C11507A, EXP. October 2021.  The product can be identified as a 5mL vial stoppered with a rubber stopper and sealed with aluminum seal having an Aqua color flip-off seal.  Meitheal commenced shipping the product to customers on August 19, 2020 which was distributed to wholesalers nationwide in the USA.

- Cisatracurium Besylate Injection, USP 10mg per 5mL. Lot Number: C11507A*. Expiration Date: October 2021*. NDC Number: 71288-712-06 (unit of sale) |71288-712-05 (unit of use). Distribution Dates: August 19, 2020 – January 04, 2021.

*Note: Mis-labeled product will have this same Lot Number of C11507A and Expiration Date of October 2021 but will be labeled on the vial as Phenylephrine Hydrochloride Injection, USP 100mg per 10mL, NDC 71288-808-77 (unit of use).

Meitheal has notified its distributors and customers in writing to arrange for return of all recalled product. Customers who have purchased the product should not open the carton or use its contents and should immediately quarantine and return the recalled lot of product. Customers who may have further distributed this product should promptly identify their customers and notify them at once of this product recall.

Consumers with questions regarding this recall can contact Meitheal’s Customer Service weekdays 8:00AM to 6:00PM CST at 844-824-8426. Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this drug product.

Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail or by fax, as follows.

Check the full recall details on fda.gov

Source: FDA
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February 5, 2021 8:50 PM

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January 28, 2021 7:00 PM

“Company name: Wahl Clipper Corporation
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FDA Recall date: January 28, 2021
Recall details: Wahl Clipper Corporation is voluntarily... See Morerecalling all Deluxe Heat Therapy Massagers, Model 4212. Discontinue use immediately. The connection between the massager and heat attachment can overheat causing smoke or spark, which may pose a fire hazard. The image below shows the area where smoke or sparks may appear.

If you own a Deluxe Heat Therapy Massager, call us at 800-767-9245 or email at techsupport@wahlclipper.com. We will facilitate the free return of your unit in exchange for a full refund plus an additional $10 for this inconvenience. Your safety is important to Wahl Clipper Corporation. If you have any questions concerning this voluntary product recall, please contact us.

Check the full recall details on fda.gov

Source: FDA
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Reported By SafelyHQ.com User