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Showing 9601–9620 of 14370 results

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Tri-Mix Injection (Apothecary) – sterility monitoring (2015)

Lack of Assurance of Sterility: Due to lack of documentation of proper environmental monitoring during the time in which the medication was produced.

Class IIModerate

FDAJun 26, 2015OK• The Apothecary Shoppe LLC

SIU-Tri-Mix 17/0.6/5.7 Injection (Apothecary Shoppe) – sterility concern (2015)

Lack of Assurance of Sterility: Due to lack of documentation of proper environmental monitoring during the time in which the medication was produced.

Class IIModerate

FDAJun 26, 2015OK• The Apothecary Shoppe LLC

SIU-Tri-Mix 20/1 mg/10 mcg/mL (Apothecary Shoppe) – sterility concern (2015)

Lack of Assurance of Sterility: Due to lack of documentation of proper environmental monitoring during the time in which the medication was produced.

Class IIModerate

FDAJun 26, 2015OK• The Apothecary Shoppe LLC

Absorica (Ranbaxy) – undeclared yellow dye (2015)

Undeclared Allergen

Incorrect/Undeclared Excipients: Product contains undeclared FD&C Yellow No. 5 in the capsule shell.

Class IIModerate

FDAJun 26, 2015Nationwide• Ranbaxy Inc.

Desmopressin Acetate Tablets (American Health) – incorrect tablet imprint (2015)

Tablets/Capsules Imprinted with Wrong ID: Some tablets incorrectly imprinted with an X on one side.

FDAJun 26, 2015Nationwide• American Health Packaging

Phent/PGE1 Injection (Apothecary) – sterility monitoring (2015)

Lack of Assurance of Sterility: Due to lack of documentation of proper environmental monitoring during the time in which the medication was produced.

Class IIModerate

FDAJun 26, 2015OK• The Apothecary Shoppe LLC

Phentolamine Injection (Apothecary) – sterility monitoring (2015)

Lack of Assurance of Sterility: Due to lack of documentation of proper environmental monitoring during the time in which the medication was produced.

Class IIModerate

FDAJun 26, 2015OK• The Apothecary Shoppe LLC

Prostaglandin E1 Injection (Apothecary) – sterility monitoring (2015)

Lack of Assurance of Sterility: Due to lack of documentation of proper environmental monitoring during the time in which the medication was produced.

Class IIModerate

FDAJun 26, 2015OK• The Apothecary Shoppe LLC

Methylcobalamin 1000 mcg/mL Injection (Apothecary Shoppe) – sterility concern (2015)

Lack of Assurance of Sterility: Due to lack of documentation of proper environmental monitoring during the time in which the medication was produced.

Class IIModerate

FDAJun 26, 2015OK• The Apothecary Shoppe LLC

Testosterone Cypionate 200 mg/mL Injection (Apothecary Shoppe) – sterility concern (2015)

Lack of Assurance of Sterility: Due to lack of documentation of proper environmental monitoring during the time in which the medication was produced.

Class IIModerate

FDAJun 26, 2015OK• The Apothecary Shoppe LLC

SIU-Papav/Phent 24/1 mg Injection (Apothecary Shoppe) – sterility concern (2015)

Lack of Assurance of Sterility: Due to lack of documentation of proper environmental monitoring during the time in which the medication was produced..

Class IIModerate

FDAJun 26, 2015OK• The Apothecary Shoppe LLC

Methylcobalamin 5000 mcg/mL Injection (Apothecary Shoppe) – sterility concern (2015)

Lack of Assurance of Sterility: Due to lack of documentation of proper environmental monitoring during the time in which the medication was produced.

Class IIModerate

FDAJun 26, 2015OK• The Apothecary Shoppe LLC

Prostaglandin E1 500 mcg/mL Injection (Apothecary Shoppe) – sterility concern (2015)

Lack of Assurance of Sterility: Due to lack of documentation of proper environmental monitoring during the time in which the medication was produced.

Class IIModerate

FDAJun 26, 2015OK• The Apothecary Shoppe LLC

Methylcobalamin Injection (Apothecary) – sterility monitoring (2015)

Lack of Assurance of Sterility: Due to lack of documentation of proper environmental monitoring during the time in which the medication was produced.

Class IIModerate

FDAJun 26, 2015OK• The Apothecary Shoppe LLC

SIU-Tri-Mix 30/2/20 Injection (Apothecary Shoppe) – sterility concern (2015)

Lack of Assurance of Sterility: Due to lack of documentation of proper environmental monitoring during the time in which the medication was produced.

Class IIModerate

FDAJun 26, 2015OK• The Apothecary Shoppe LLC

Tri-Mix Injectable (Apothecary) – sterility monitoring (2015)

Lack of Assurance of Sterility: Due to lack of documentation of proper environmental monitoring during the time in which the medication was produced.

Class IIModerate

FDAJun 26, 2015OK• The Apothecary Shoppe LLC

Papav/Phentol Injection (Apothecary) – sterility monitoring (2015)

Lack of Assurance of Sterility: Due to lack of documentation of proper environmental monitoring during the time in which the medication was produced.

Class IIModerate

FDAJun 26, 2015OK• The Apothecary Shoppe LLC

Acetylcysteine Ophthalmic Solution (Apothecary) – sterility concerns (2015)

Lack of Assurance of Sterility: Due to lack of documentation of proper environmental monitoring during the time in which the medication was produced.

Class IIModerate

FDAJun 26, 2015OK• The Apothecary Shoppe LLC

Testosterone Cypionate Injection (Apothecary Shoppe) – sterility concern (2015)

Lack of Assurance of Sterility: Due to lack of documentation of proper environmental monitoring during the time in which the medication was produced.

Class IIModerate

FDAJun 26, 2015OK• The Apothecary Shoppe LLC

Chorionic Gonad HCG Injection (Apothecary) – sterility monitoring (2015)

Lack of Assurance of Sterility: Due to lack of documentation of proper environmental monitoring during the time in which the medication was produced.

Class IIModerate

FDAJun 26, 2015OK• The Apothecary Shoppe LLC

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