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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
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
