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Showing 3441–3460 of 14370 results

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Mini Gummi Butterflies (Albanese) – Supplement Contamination (2021)

Product contains comingled Olly Sleep dietary supplement which may cause drowsiness

Class IIModerate

FDAAug 18, 2021IN, MI, OK• Albanese Confectionery Group, Inc.

Spironolactone Ophthalmic Solution (Greenpark) – Sterility Concern (2021)

Lack of Assurance of Sterility

Class IIModerate

FDAAug 18, 2021Nationwide• Prescription Labs Inc dba Greenpark

Carvedilol Tablets (RemedyRepack) – Incorrect Tablet Mix (2021)

A 500 count bottle of Carvedilol 25 mg tablets contained two Paroxetine Tablets, 40 mg. Product was repackaged into 180 count bottles.

Class IIModerate

FDAAug 17, 2021FL, IN, VA• RemedyRepack Inc.

Sodium Phenylbutyrate Powder (SigmaPharm) – Impurity Specification Failure (2021)

Failed Impurities Specifications: Out of Specification impurity results obtained during routine testing.

Class IIModerate

FDAAug 13, 2021Nationwide• SigmaPharm Laboratories LLC

Chantix (Pfizer) – Impurity Risk (2021)

CGMP Deviations: Presence of the N-nitroso-varenicline impurity above FDA s acceptable interim acceptable intake limit

Class IIModerate

FDAAug 13, 2021Nationwide• Pfizer Inc.

Test CYP/Prop 160/40mg/ml Injection (Red Mountain) – Sterility Concerns (2021)

Lack of Assurance of Sterility: FDA inspection raised sterility assurance concerns

Class IIModerate

FDAAug 13, 2021AZ, CA, FL +5 more• First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy

Acetylcysteine 2% Ophth Solution (Red Mountain) – Sterility Concerns (2021)

Lack of Assurance of Sterility: FDA inspection raised sterility assurance concerns

Class IIModerate

FDAAug 13, 2021AZ, CA, FL +5 more• First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy

Levocarnitine (Red Mountain) – Sterility Concerns (2021)

Lack of Assurance of Sterility: FDA inspection raised sterility assurance concerns

Class IIModerate

FDAAug 13, 2021AZ, CA, FL +5 more• First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy

Methylcobalamin Injection (Red Mountain) – Sterility Concerns (2021)

Lack of Assurance of Sterility: FDA inspection raised sterility assurance concerns

Class IIModerate

FDAAug 13, 2021AZ, CA, FL +5 more• First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy

Dexpanthenol Injection (Red Mountain) – Sterility Concerns (2021)

Lack of Assurance of Sterility: FDA inspection raised sterility assurance concerns

Class IIModerate

FDAAug 13, 2021AZ, CA, FL +5 more• First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy

Testosterone Cypionate (Red Mountain) – Sterility Concerns (2021)

Lack of Assurance of Sterility: FDA inspection raised sterility assurance concerns

Class IIModerate

FDAAug 13, 2021AZ, CA, FL +5 more• First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy

Estradiol Valerate (Red Mountain) – Sterility Concerns (2021)

Lack of Assurance of Sterility: FDA inspection raised sterility assurance concerns

Class IIModerate

FDAAug 13, 2021AZ, CA, FL +5 more• First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy

Cyclosporine Suspension (Red Mountain) – Sterility Concerns (2021)

Lack of Assurance of Sterility: FDA inspection raised sterility assurance concerns

Class IIModerate

FDAAug 13, 2021AZ, CA, FL +5 more• First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy

MIC Injection (Red Mountain) – Sterility Concerns (2021)

Lack of Assurance of Sterility: FDA inspection raised sterility assurance concerns

Class IIModerate

FDAAug 13, 2021AZ, CA, FL +5 more• First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy

Testosterone Cypionate (Red Mountain) – Sterility Concerns (2021)

Lack of Assurance of Sterility: FDA inspection raised sterility assurance concerns

Class IIModerate

FDAAug 13, 2021AZ, CA, FL +5 more• First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy

Hydroxyprogesterone (Red Mountain) – Sterility Concerns (2021)

Lack of Assurance of Sterility: FDA inspection raised sterility assurance concerns

Class IIModerate

FDAAug 13, 2021AZ, CA, FL +5 more• First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy

Betamethasone Dipropionate Lotion 0.05% (Akorn) – Impurity Specification (2021)

Failed impurities/degradation specification: Out of Specification for an unknown impurity observed in topical product.

Class IIModerate

FDAAug 13, 2021Nationwide• Akorn, Inc.

MIT/B12 25/50/50mg/ml Injection (Red Mountain) – Sterility Concerns (2021)

Lack of Assurance of Sterility: FDA inspection raised sterility assurance concerns

Class IIModerate

FDAAug 13, 2021AZ, CA, FL +5 more• First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy

Test CYP 200mg/ml Injection (Red Mountain) – Sterility Concerns (2021)

Lack of Assurance of Sterility: FDA inspection raised sterility assurance concerns

Class IIModerate

FDAAug 13, 2021AZ, CA, FL +5 more• First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy

Test CYP 25mg/ml Injection (Red Mountain) – Sterility Concerns (2021)

Lack of Assurance of Sterility: FDA inspection raised sterility assurance concerns

Class IIModerate

FDAAug 13, 2021AZ, CA, FL +5 more• First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy

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