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  1. #1
    Elite PillarofBalance's Avatar
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    Pfizer Crashed Test Cyp

    happens to the best of em' so don't panic


    July 6, 2011


    Pfizer Inc
    100 Route 206 North
    Peapack, NJ 07977
    Email: pfizerinjectables@pfizer.com

    Established Products Business Unit
    Depo®-Testosterone (testosterone cypionate injection, USP) 200 mg/mL


    Recent investigation, at the Pfizer Kalamazoo site, into a higher-than-usual frequency of product complaints on Depo ®-Testosterone 200 mg/mL (NDC 0009-0417-01 and NDC 0009-0417-02) has found that although crystals are being observed at a higher than historical rate in a few recent lots, the product poses no risk to patient safety, efficacy, or product quality when the US Product Insert (USPI) instructions are followed prior to administration.

    Depo®-Testosterone 200 mg/mL is a very highly concentrated (supersaturated) sterile solution for injection, comprised of cottonseed oil, testosterone cypionate and benzyl alcohol. The high concentration of active ingredient makes the product very susceptible to crystallization when exposed to a temperature lower than recommended on the label [20°C to 25°C (68°F to 77°F)].

    This product attribute is well known and is specifically addressed with instructions in both the USPI and on the product vial label. The USPI states; “Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. Warming and shaking the vial should redissolve any crystals that may have formed during storage at temperatures lower than recommended.”
    In addition, the current approved vial label for the US market states; “Warming and shaking the vial should re-dissolve any crystals that may have formed during storage at temperatures lower than recommended.”
    Extensive investigation at the Kalamazoo site into the recent complaint lots has concluded that the product meets all registered product specifications when the USPI and vial label instructions are followed prior to administration. Dissolution of crystals in all returned complaint samples has been achieved by warming and shaking the vials.
    Analysis of retain and returned compliant samples confirm the product potency at the labeled strength, 200 mg/mL.

    Evaluation by Pfizer Medical and Safety indicated that there were no adverse events associated with crystal formation and crystal formation has no impact on efficacy, quality or safety of the product. The formation of crystals in a super saturated solution of testosterone cypionate is a well known occurrence which is clearly addressed in the vial label with instructions to re-suspend via warming and shaking.

    Potency testing from these lots confirms two key product quality attributes:
     the product can be warmed, shaken, and the crystals re-dissolved, when prepared according to instructions found in the product insert and on the vial label; and,
     the potency of the retain and complaint samples confirm product potency at the labeled strength (200 mg/mL).

    Based on our testing of and a medical and safety evaluation, all distributed lots of Depo®-Testosterone 200 mg/mL continue to be acceptable for use, regardless of the presence of crystals, when used as directed in the product insert.

    This communication and updated product information is available on the Pfizer Injectables Web site www.pfizerinjectables.com.

    Please direct any questions related to the content of this letter to Pfizer Medical Information at 1-800-438-1985.

    Sincerely,

    Pfizer Injectables

  2. #2
    Elite 63Vette's Avatar
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    Re: Pfizer Crashed Test Cyp

    Hahahahahahaa... ****ers.... Warming and shaking sounds like a good pp workout to me.... lol

    Respect,
    Vette
    Hung like Einstein and Smart as a Mule.

  3. #3
    Elite PFM's Avatar
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    Re: Pfizer Crashed Test Cyp

    Properly dosed Cyp is prone to crash, enter cold temps into the equation and you have recrystallization. Nature of the beast AKA It's good shit ;-)
    Thugs
    Don't
    Matter

  4. #4
    Elite LeanHerm's Avatar
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    Re: Pfizer Crashed Test Cyp

    That's why we have ovens and timers. Lol

  5. #5
    Elite. Flyingdragon's Avatar
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    Re: Pfizer Crashed Test Cyp

    The point of the article is to prove even Big Pharma can not prevent gear from crashing...

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