Class II · Moderate risk Ongoing
Ascorbic Acid 500 mg/mL (50 ML). Compounded by Tri-Coast Pharmacy.
Reason Lack of Assurance of Sterility
FDA Drug Recalls
2,277 recalls · Class II, newest first
Class II · Moderate risk Ongoing
Amino Acid Recover Eaze (50 ML), Phenylaline (L) 8 mg/ml + Tyrosine (L) 0.45 mg/ml + L-Taurine 0.7 mg/ml. Compounded by…
Reason Lack of Assurance of Sterility
Class II · Moderate risk Ongoing
Amino Energy Cocktail (30 ML), (Methionine (L) 12.5 mg/Inositol 25 mg/Choline Chloride 25 mg/Methylcobalamin 300 mcg/Carnitine…
Reason Lack of Assurance of Sterility
Class II · Moderate risk Ongoing
LGD-Xtreme (ligandrol LGD-4033),capsules, 3 mg, 90-count bottle, Manufactured for Continuum Labs, Fort Lauderdale, FL
Reason Marketed Without An Approved NDA/ANDA: Contains an unapproved drug, ligandrol LGD-4033
Class II · Moderate risk Ongoing
Screenses Color Sunscreen, Tinted facial make-up compact, Broad Spectrum SPF 50 Light, 0.35 oz (10 g), Manufactured by Sesderma…
Reason cGMP Deviations; product does not comply with cGMP requirements
Class II · Moderate risk Ongoing
Screenses Color Sunscreen Tinted facial make-up compact, Broad Spectrum SPF 50, Brown, 0.35 oz (10 g), Manufactured by Sesderma…
Reason cGMP Deviations; product does not comply with cGMP requirements
Class II · Moderate risk Ongoing
Repaskin 30 (octacrylene 4%, oxybenzone 3%, octisalate 3%, octinoxate 3% Avobenzone 3%) Facial Sunscreen gel cream, Broad…
Reason cGMP Deviations; product does not comply with cGMP requirements
Class II · Moderate risk Ongoing
Repaskin 50 (octocrylene 7%, titanium oxide 2%) Facial Sunscreen gel cream, Broad Spectrum SPF 50, 1.7 fl oz (50 mL) tube, over…
Reason cGMP Deviations; product does not comply with cGMP requirements
Class II · Moderate risk Ongoing
Dryses Aluminum Chlorohydrate Deodorant for Women, Roll-on, 2.5 fl oz (75 mL) bottle, over the counter, Manufactured by Sesderma…
Reason cGMP Deviations; product does not comply with cGMP requirements
Class II · Moderate risk Ongoing
Dryses Aluminum Chlorohydrate Deodorant for Men Roll-on, 2.5 fl oz (75 mL) bottle, over the counter, Manufactured by Sesderma…
Reason cGMP Deviations; product does not comply with cGMP requirements
Class II · Moderate risk Ongoing
Repaskin 30 (octacrylene 4%, oxybenzone 3%, octisalate 3%, octinoxate 3% Avobenzone 3%) Body Lotion Sunscreen gel cream, Broad…
Reason cGMP Deviations; product does not comply with cGMP requirements
Class II · Moderate risk Ongoing
Repaskin 50 (octocrylene 7%, titanium dioxide 2%) Body Lotion Sunscreen gel cream, Broad Spectrum SPF 50, 6.8 fl oz (200 mL)…
Reason cGMP Deviations; product does not comply with cGMP requirements
Class II · Moderate risk Ongoing
Salises Facial Moisturizing Acne Treatment Gel, (salicylic acid 1.5%), 1.7 fl. oz (50 mL) bottle, over the counter, Manufactured…
Reason cGMP Deviations; product does not comply with cGMP requirements
Class II · Moderate risk Ongoing
Dryses Aluminum Chlorohydrate Antiperspirant Solution, 3.4 fl. oz (100 mL) bottle, over the counter, Manufactured by Sesderma…
Reason cGMP Deviations; product does not comply with cGMP requirements
Class II · Moderate risk Ongoing
1% Lidocaine HCl Injection, USP, 10 mg/mL, 30 mL Vial, Single-dose Preservative Free, Rx only, Hospira, Inc., Lake Forest, IL…
Reason Presence of Particulate Matter: particulate matter identified as iron oxide, was found embedded in the neck of glass vials.
Class II · Moderate risk Ongoing
KETOROLAC Tromethamine Inj., USP, 60 mg (30 mg/mL), 2 mL Fill Single-dose Vials, I.V/I.M. USE, Hospira, Inc., Lake Forest, IL…
Reason Crystallization; identified as calcium salt of Ketorolac
Class II · Moderate risk Ongoing
KETOROLAC Tromethamine Inj., USP, 30 mg (30 mg/mL), 1 mL Fill, Single-dose Vials, I.V/I.M. USE, Hospira, Inc., Lake Forest, IL…
Reason Crystallization; identified as calcium salt of Ketorolac
Class II · Moderate risk Ongoing
Ceftriaxone 1 gm/50 mL D5W, Trinity Care Solutions, 202-C SW 17th Street, Ocala, FL 34471-5138, For Parenteral Use Only, Rx #…
Reason Lack of Assurance of Sterility; All lots of sterile products compounded by the pharmacy within expiry are subject to this recall. This recall is…
Class II · Moderate risk Ongoing
Cefepime 2 gm/100 mL 0.9%NS, Trinity Care Solutions, 202-C SW 17th Street, Ocala, FL 34471-5138, For Parenteral Use Only, Rx #…
Reason Lack of Assurance of Sterility; All lots of sterile products compounded by the pharmacy within expiry are subject to this recall. This recall is…
Class II · Moderate risk Ongoing
Ceftriaxone 2 gm/100 mL D5W, Trinity Care Solutions, 202-C SW 17th Street, Ocala, FL 34471-5138, For Parenteral Use Only, Rx #…
Reason Lack of Assurance of Sterility; All lots of sterile products compounded by the pharmacy within expiry are subject to this recall. This recall is…
Class II · Moderate risk Ongoing
Cefepime 1 gm/100 mL 0.9%NS, Trinity Care Solutions, 202-C SW 17th Street, Ocala, FL 34471-5138, For Parenteral Use Only, Rx #…
Reason Lack of Assurance of Sterility; All lots of sterile products compounded by the pharmacy within expiry are subject to this recall. This recall is…
Class II · Moderate risk Ongoing
Cubicin 700 mg/100 mL 0.9%NS, Trinity Care Solutions, 202-C SW 17th Street, Ocala, FL 34471-5138, For Parenteral Use Only, Rx #…
Reason Lack of Assurance of Sterility; All lots of sterile products compounded by the pharmacy within expiry are subject to this recall. This recall is…
Class II · Moderate risk Ongoing
Cubicin 600 mg/100 mL 0.9%NS, Trinity Care Solutions, 202-C SW 17th Street, Ocala, FL 34471-5138, For Parenteral Use Only, Rx #…
Reason Lack of Assurance of Sterility; All lots of sterile products compounded by the pharmacy within expiry are subject to this recall. This recall is…
Class II · Moderate risk Ongoing
Cubicin 543 mg/100 mL 0.9%NS, Trinity Care Solutions, 202-C SW 17th Street, Ocala, FL 34471-5138, For Parenteral Use Only, Rx #…
Reason Lack of Assurance of Sterility; All lots of sterile products compounded by the pharmacy within expiry are subject to this recall. This recall is…
Class II · Moderate risk Ongoing
Vancomycin 1.25 gm/100 mL 0.9%NS, Trinity Care Solutions, 202-C SW 17th Street, Ocala, FL 34471-5138, For Parenteral Use Only, Rx…
Reason Lack of Assurance of Sterility; All lots of sterile products compounded by the pharmacy within expiry are subject to this recall. This recall is…