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Meitheal Cisatracurium Besylate Injection - recalled due to Mislabeling, USA

January 27, 2021 9:01 PM

United States

Company name: Meitheal Pharmaceuticals, Inc.
Brand name: Meitheal Pharmaceuticals, Inc.
Product recalled: Cisatracurium Besylate Injection, USP 10mg per 5mL
Reason of the recall: Mislabeling
FDA Recall date: January 27, 2021
Recall details: Meitheal Pharmaceuticals, Inc. (“Meitheal”), announced today that it is voluntarily recalling one (1) lot of Cisatracurium Besylate Injection, USP 10mg per 5mL to the user level. The decision to recall the product was made after a product complaint revealed that a portion of Lot C11507A of cartons labeled as Cisatracurium Besylate Injection, USP 10mg per 5mL, containing 10-vials per carton, contained 10-vials mis-labeled as Phenylephrine Hydrochloride Injection, USP 100mg per 10mL. 

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

Reported By SafelyHQ.com User
More incidents from:
Drugs
Recall
United States

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Brand name: Apotex Corp.
Product recalled: Enoxaparin Sodium Injection, USP
Reason of the recall: Packaging error resulting in incorrect dosage listed
FDA Recall date: February 03, 2021
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Health Hazard Assessment: Incorrect syringe barrel marking could lead to miscalculation and inaccurate dose administration to patients. In one recalled batch (batch CS008, strength 100 mg/mL), if a consumer used a 150 mg/mL concentration packaged in a barrel corresponding to a l00 mg/mL concentration, patients could receive 3.75 mg of Enoxaparin, instead of 3 mg of Enoxaparin. In another recalled batch (batch CT003, strength 120 mg/0.8mL), if a consumer used a 100 mg/mL concentration packaged in a barrel corresponding to a 150 mg/mL concentration, patients would receive 2 mg of Enoxaparin rather than 2.5 mg of Enoxaparin. Accidental overdosage following administration of enoxaparin sodium injection may lead to bleeding complications. Alternative, if the dose administered is less than prescribed, the patient may be subject to developing some blood clotting conditions.

Enoxaparin Sodium injection is indicated for the prophylaxis of deep vein thrombosis (DVT), which may lead to pulmonary embolism (PE), Treatment of Acute Deep Vein Thrombosis, prophylaxis of ischemic complications of unstable angina and non-Q-wave myocardial infarction, when concurrently administered with aspirin and Treatment of Acute ST-Segment Elevation Myocardial Infarction.

The affected Enoxaparin Sodium Injection, USP can be identified by NDC numbers stated on carton and label of the product.

Product: Enoxaparin Sodium Injection, USP
Batch #: CS008
Strength: 100 mg/mL
Syringe Barrel Measurement Markings: 100 mg/mL
Pack Size: 10 x 1mL Single Dose Syringes
NDC NumberOn Carton: 60505-0795-4
NDC Number On label: 60505-0795-1
UPC Code on Carton: 360505079544
UPC Code on label: (01)10360505079510

Product: Enoxaparin Sodium Injection, USP
Batch # : CT003
Strength: 120 mg/0.8mL
Syringe Barrel Measurement Markings: 150 mg/ mL
Pack Size: 10 x 0.8 mL Single Dose Syringes
NDC NumberOn Carton: 60505-0796-4
NDC Number On label: 60505-0796-0
UPC Code on Carton: 360505079643
UPC Code on label: (01)10360505079602

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Check the full recall details on fda.gov

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FDA Recall date: February 10, 2021
Recall details: NDAL MFG INC is voluntarily recalling one lot of Manukaguard Allercleanse, nasal spray to the consume... See Morer level. The Allercleanse nasal sprays have been found to be contaminated with yeast.

Risk Statement:  The use of Allercleanse (manuka honey) nasal spray contaminated with yeasts, in the population most likely to use it (children, adults, and elderly), may result in adverse events that necessitate medical or surgical intervention. However, use of this contaminated product in immunosuppressed individuals may result in life threatening invasive fungal infections.

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Product was distributed Nationwide in the USA to 1 e-commerce website amazon.com, distributors and retail stores. NDAL MFG INC has notified its distributors and customers by e-mail followed by telephone and further email and has arranged for return/replacement etc. of all recalled products. 

Consumers/distributors/retailers that have product which is being recalled should stop using/return to place of purchase/discard/contact their doctor, etc., if they have not already done so. Consumers with questions regarding this recall can contact NDAL MFG INC by phone 1-800-916-1220 or e-mail address SUPPORT@MANUKAGUARD.COM, M-F 7:30 am to 4 pm PST.  Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this product.

Check the full recall details on fda.gov

Source: FDA
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No other batch/lot numbers or other Ridley Block Operations products are involved in this voluntary recall. Only the specific batches and lot numbers of CRYSTALYX Sheep-lyx listed above are impacted. No injuries or illnesses have been reported.

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