Sun Pharma Recalls Testosterone

[Jinzang]

The US arm of the Indian drug manufacturer Sun Pharmaceutical is recalling over 5.2 thousand units of testosterone cypionate from the American market. Sun Pharmaceutical Industries Inc is recalling 5,215 units of 10 mL vials testosterone cypionate injections in the strength of 200 mg/mL, on account of "presence of particulate matter: organic and inorganic compounds detected in vials of product." As per the report by the Food and Drug Administration (FDA), the ongoing voluntary nationwide recall is a class II recall.

Read the original article.

 

[madman]

The US arm of the Indian drug manufacturer Sun Pharmaceutical is recalling over 5.2 thousand units of testosterone cypionate from the American market. Sun Pharmaceutical Industries Inc is recalling 5,215 units of 10 mL vials testosterone cypionate injections in the strength of 200 mg/mL, on account of "presence of particulate matter: organic and inorganic compounds detected in vials of product." As per the report by the Food and Drug Administration (FDA), the ongoing voluntary nationwide recall is a class II recall.

Read the original article.

2023!

Regulatory Affairs Professionals Society | RAPS

RAPS is the largest global organization of and for those involved with the regulation of healthcare and related products, including medical devices, pharmaceuticals, biologics and nutritional products.

www.raps.org

Sun Pharmaceutical Industries Ltd. - 636199 - 10/16/2023

CGMP/Active Pharmaceutical Ingredient (API)/Adulterated

www.fda.gov

3. Your firm failed to use equipment in the manufacture, processing, packing, or holding of drug products that is of appropriate design, adequate size, and suitably located to facilitate operations for its intended use and for its cleaning and maintenance (21 CFR 211.63).

You failed to identify and use equipment suitable for the filling of your viscous parenteral drug product. Inappropriately designed vial filling equipment led to substantial extraneous matter contamination in testosterone cypionate injection 200 mg/mL, 1 ml vials. Further, your production department failed to establish adequate personnel practices and supervisory oversight to prevent the use of damaged equipment.

You determined the design of the filling equipment ((b)(4)) in combination with the viscous nature of your drug product-generated friction. This friction caused an abrasive effect on the surface of (b)(4) during (b)(4) movement which introduced blackish fine metallic particles into your vial during filling. You explained that these (b)(4) could not be fixed once damaged. Although reportedly removed from service, the damaged (b)(4) were listed as approved equipment in your master manufacturing batch record approved on April 5, 2022, approximately two years after they were identified as the root cause for cross-contamination.

Notably, one of the damaged (b)(4) (H102) was used to fill numerous batches of testosterone cypionate injection.

It is your responsibility to ensure that only appropriately designed and maintained equipment are used in the manufacture of your drug products.

We acknowledge that after our inspection you voluntarily recalled five marketed testosterone cypionate injection lots associated with the (b)(4) investigations.

Your response is inadequate. Your response fails to address the flaws in your change management system that permitted continued use of damaged and inappropriately designed (b)(4). Your response states that damaged (b)(4) were isolated and not used in filling testosterone cypionate injection but were inadvertently not removed from the manufacturing batch record. You also state that an associated (b)(4) (H102) was reconditioned and was acceptable for use. However, your firm indicated during the inspection that these damaged (b)(4) could not be reconditioned and acknowledged that they were not suitably designed. Your response also did not include a risk assessment that thoroughly evaluates the design and lifecycle control of manufacturing equipment including (b)(4) and (b)(4).


In response to this letter, provide:

• Your CAPA plan to implement routine, vigilant operations management oversight (corporate and local) of facilities and equipment. This plan should ensure, among other things, prompt detection of equipment/facilities performance issues, effective execution of repairs, adherence to appropriate preventive maintenance schedules, timely technological upgrades to the equipment/facility infrastructure, appropriately qualified production management personnel, and improved systems for ongoing management review. Your plan should also ensure that appropriate actions are taken throughout the company network.
• A thorough evaluation and risk assessment that addresses the suitability of your equipment for its intended use. You should include a determination of whether equipment is of appropriate design and a robust program for ongoing control and maintenance. Also describe how Quality Assurance will oversee the efficacy of systems used by operations to accomplish these critical objectives.
• An independent retrospective review of your manufacturing batch records to ensure that defective (b)(4) manufactured by (b)(4) or (b)(4) were not used during filling operations.
• An independent retrospective review of all complaints, including the associated investigations, for discoloration and particulates, for sterile drug products within expiry as of the date of this letter. Include the drug product name, batch number, and date of manufacture, line number, along with a summary of the complaint, description of likely root cause(s), CAPA plan, and status of CAPA.
• An independent, comprehensive review of your complaint system that identifies deficiencies in the system and corresponding CAPA that are needed.
• A comprehensive, independent assessment of your change management system. This assessment should include, but not be limited to, your procedure(s) to ensure changes are appropriately justified, evaluated, and reviewed to a final determination of acceptability by your QU. Your change management program should include provisions for determining change effectiveness.

 

[BigTex]

OK, so what do people do that have this crap, they didn't exactly explain that. I have 2 bottles that I got from CVS. I guess I could draw the oil out of the vial and run it through a .22 filter and put it in a new vial. Holy crap, how can a big pharma company screw up something like that.

 

[Dicky]

OK, so what do people do that have this crap, they didn't exactly explain that. I have 2 bottles that I got from CVS. I guess I could draw the oil out of the vial and run it through a .22 filter and put it in a new vial. Holy crap, how can a big pharma company screw up something like that.

Can you take it back to CVS? I would hope that they would be aware of the recall and would help facilitate some kind of exchange

 

[BigTex]

I jst talked to about 15 other guys last night that are also getting Sun Pharama test. Most of them get the 1ml vials. I think I will give CVS a call today.

 

[tareload]

Thanks for the info. I injected some Sun Pharma 1 ml stuff this AM. Great. We are all running UGL gear now.

I'll let you know if I get sick. I don't see any current recalls for the 1 mL vials.

 

[tareload]

Previous recall (2022):

Testosterone Injection Recalled

A Class II recall has been issued for several lots of testosterone injection due to concerns over product impurities and sterility.

www.hmpgloballearningnetwork.com

https://www.pharmacy.ca.gov/about/recall_alerts/060822_sun.pdf

 

[tareload]

Nothing here...yet.

Recall Alerts - Sun Pharma USA

sunpharma.com

So the 2023 reference above appears misleading to me. That said, I probably won't be taking any more Sun Pharma products.

Import Alert 66-40

 

[tareload]

And the NASEM report cites compounded drugs as being a potential safety risk to patients. HAHA.

I would call the violations above a significant risk to patient safety.

Sorry I've been so hard on all you conscientious UGL vendors. Surely you have someone on staff that can do better than above?

 

[tareload]

I would hope that they would be aware of the recall

See my posts above. There is no recall...yet. Last one by Sun Pharma was voluntary recall (June 2022). Sun Pharma is on import ban since Dec 7, 2022. The Govt is perfectly fine with you injecting potentially contaminated gear even though compounded pharmacies are a huge threat that must be reigned in [sarcasm].

 

[tareload]

Thanks for the info. I injected some Sun Pharma 1 ml stuff this AM. Great. We are all running UGL gear now.

I'll let you know if I get sick. I don't see any current recalls for the 1 mL vials.

24 hour update. Not dead yet and no injection site issues. Expiration date on my vials is in 2024 so made before the import ban and after June 2022 voluntary recall (Murphy's law).

 

[BigTex]

Thanks for the info. I injected some Sun Pharma 1 ml stuff this AM. Great. We are all running UGL gear now.

I'll let you know if I get sick. I don't see any current recalls for the 1 mL vials.

Here is part of what @madman posted:

Lastly, equipment was not suitable designed for filling of viscous parenteral drug product. “Inappropriately designed vial filling equipment led to substantial extraneous matter contamination in testosterone cypionate injection 200 mg/mL, 1 ml vials. Further, your production department failed to establish adequate personnel practices and supervisory oversight to prevent the use of damaged equipment.”​

​

I have seen some UG labs that have top notch equipmment and do a much better job. Substancial extraneous matter?

I can't wait to tell my doctor about this when I see him today. He already said, "don't we make anything in America any longer."

I did notice that the 1st posting recall was dated August 2018. So my 10ml vials may not have substancial extraneous matter in them.

 

[BigTex]

CVS is absolutely fine with selling these products as well as selling products that are about to expire. I got the last two bottles in April of 2022 and have an expiration date in 2023. I may have to go back to burying UG products.

 

[tareload]

Let's get that RV @BigTex. We can do better!




Pathetic. About the simplest formulation you can manufacture.

 

[DaveK22]

I may have to go back to burying UG products.

I actually use T Cyp from UGL. Years ago after dealing with insurance BS, I did quite a bit of DD on a few steroid forums and found the UGL brands that have the "Bro' experts" claiming it's legit. Some had product test lab reports to backup claims. My brand has a QR code on box & also a scratch off halogram decal which has a serial number...then u can verify product on manf website. I realize there is no guarantees on any of that but to each their own. I figure the beef I buy has more contamination than my ugl stuff...but rather not think about it lol

I'm not promoting or suggesting using UGL...but for me it works. I recently bought a 10ml vial 250mg/ml for $48 which will last me 6 months. Plus it's a grape seed oil & silicone stopper on vial (much easier on needle than rubber)... a plus for using 30g insulin pins