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M1-Alpha Mega Mass Builder (Anabolic Science) - Unapproved Hormone (2014)

Marketed without an approved NDA/ANDA - These products are being recalled due to the presence of synthetic hormone/prohormone (methylated anabolic steroid) ingredient making them unapproved new drugs.

Class IHigh

FDADec 12, 2014Nationwide• Anabolic Science Labs, LLC

Hydroxocobalamin Injection (American Specialty) - Particulate Matter (2014)

Presence of Particulate Matter; preservative may not have dissolved completely or precipitated out of product

Class IIModerate

FDADec 12, 2014TX• American Specialty Pharmacy

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M1-Alpha Mega Mass Builder (Anabolic Science) - Unapproved Hormone (2014)

Hydroxocobalamin Injection (American Specialty) - Particulate Matter (2014)

Glutathione Injectable (Right Value) - Incorrect Gas Used (2014)

M14-MENT Mass Builder (Anabolic Science) - Unapproved Hormone (2014)

Swoll-250 Super Mass Builder (Anabolic Science) - Unapproved Hormone (2014)

Estrastain Pro-Anabolic Complex (Anabolic Science) - Unapproved Hormone (2014)

Halo-70 Mega Mass Builder (Anabolic Science) - Unapproved Hormone (2014)

7-MENT Alpha Mass Builder (Anabolic Science) - Unapproved Hormone (2014)

Professional Formexx Black (Anabolic Science) - Unapproved Hormone (2014)

Triamcinolone Acetonide Lotion (Akorn) - Impurity Specification (2014)

Sulfur8 Anti-Dandruff Conditioner (J. Strickland) - pH Specification Failure (2014)

Belviq Tablets (Eisai) - Missing Label Details (2014)

Fluoxetine Capsules (Sandoz) - Illegible Logo (2014)

Eye Drops A.C. (K C Pharmaceuticals) – Non-Compliant Storage (2014)

Eye Drops Advanced Relief (K C Pharmaceuticals) – Non-Compliant Storage (2014)

Simvastatin Tablets 20mg (Micro Labs) – Impurity Specification (2014)

Eye Drops (K C Pharmaceuticals) – Non-Compliant Storage (2014)

Simvastatin Tablets 80mg (Micro Labs) – Impurity Specification (2014)

Eye Drops Industrial Strength (K C Pharmaceuticals) – Non-Compliant Storage (2014)

Sodium Chloride Injection (Baxter) - Plastic Contamination (2014)