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Nostrum Laboratories, Inc. Metformin HCl Extended Release Tablets, USP 750 mg - recalled due to Due to levels of nitrosamine impurities above the ADI limit of 96 ng/day, USA

January 25, 2021 7:00 PM

United States

Company name: Nostrum Laboratories, Inc.
Brand name: Nostrum Laboratories, Inc.
Product recalled: Metformin HCl Extended Release Tablets, USP 750 mg
Reason of the recall: Due to levels of nitrosamine impurities above the ADI limit of 96 ng/day
FDA Recall date: January 25, 2021
Recall details: Kansas City, Missouri,Nostrum Laboratories, Inc. is voluntarily recalling one lot of Metformin HCl Extended Release Tablets, USP 750 mg (generic equivalent to Glucophage Tablets) to the consumer level. The Metformin HCl Extended Release Tablets, USP 750 mg (generic equivalent to Glucophage Tablets) have been found to contain levels of nitrosamine impurities above the ADI limit of 96 ng/day, as published in the FDA Guidance Document issued September 2020. This is an expansion of the recall initially announced on November 2nd 2020. NDMA is classified as a probable human carcinogen (a substance that could cause cancer) based on results from laboratory tests. 

NDMA is a known environmental contaminant and found in water and foods, including meats, dairy products, and vegetables. To date, Nostrum Laboratories, Inc. has not received any reports of adverse events related to this recall.

The product is indicated as an adjunct to diet and exercise to improve blood glucose control in adults with type 2 diabetes mellitus and is packaged in HDPE bottles of 100 tablets, under NDC 29033-056-01. The affected Metformin HCl Extended Release Tablets, USP 750 mg (generic equivalent to Glucophage Tablets) lot is listed in the table below. The product can be identified as an off-white oblong tablet debossed with “NM7”. Metformin HCl Extended Release Tablets, USP 750 mg (generic equivalent to Glucophage Tablets) was distributed Nationwide in the USA to wholesalers who further distributed to pharmacies and patients.

- Product Description: Metformin HCl Extended Release Tablets, USP 750 mg (generic equivalent to Glucophage Tablets)
- NDC: 29033-056-01
- Lot Number: MET200601
- Expiry Dates: 07/2022

Nostrum Laboratories, Inc. is notifying its distributors by letter and is arranging for return of all recalled products. Consumers with medical questions regarding this recall can contact Nostrum Laboratories, Inc. Medical Affairs at phone number 816-308-4941 or email quality@nostrumpharma.com Monday through Friday from 8 am – 5 pm CST. Consumers should contact their physician or pharmacy for further medical advice.

Check the full recall details on fda.gov

Source: FDA

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

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January 27, 2021 9:01 PM

“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”), annou... See Morenced 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.

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Check the full recall details on fda.gov

Source: FDA
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February 3, 2021 1:00 PM

“Company name: Apotex Corp
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
Recall details: Apotex Corp is voluntarily recalling two (2) batches of Enoxaparin... See MoreSodium Injection, USP to consumer level due to a packaging error resulting in some syringes barrels containing 150 mg/mL markings (corresponding to 120 mg/0.8mL strength) instead of 100 mg/mL markings (corresponding to 100 mg/mL strength) on the syringe barrel and vice versa. The packaging error was discovered during a customer complaint investigation. To date, Apotex has not received any reports of adverse events related to use of these two batches. The affected product is manufactured by Gland Pharma Limited, Hyderabad, India.

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

The two (2) affected batches of Enoxaparin Sodium Injection, USP were distributed by Apotex nationwide in the USA to Wholesalers and Warehousing Chains. Apotex Corp. is currently notifying its affected direct account Wholesalers and Warehousing Chains, via mail (FedEx Standard Overnight) by mailing a recall notification letter and is arranging for return of all recalled product.

Check the full recall details on fda.gov

Source: FDA
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