FDA Recall
Terminated
Historical recordClass I
Metronidazole Injection USP, 500 mg per 100 mL (5 mg/mL), 100mL Sterile Single Dose Container bag, Rx only, Baxter USA, Product Code 2B3421, NDC 0338-1055-48.
by Baxter Healthcare Corp.
- Reason
- Presence of Particulate Matter: identified as a cloth fiber.
- Published
- June 1, 2016
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass I
0.9% Sodium Chloride Injection USP, MINI-BAG Plus Container, 100 mL VIAFLEX Single Dose Container bags, Rx only, Baxter Healthcare Corporation, Deerfield, IL 60015, Product Code 2B0043, NDC 0338-0553-18.
by Baxter Healthcare Corp.
- Reason
- Presence of Particulate Matter: identified as cardboard.
- Published
- June 1, 2016
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
0.9% Sodium Chloride Injection USP, MINI-BAG Plus Container, 100 mL VIAFLEX Single Dose Container bags, Rx only, Baxter Healthcare Corporation, Deerfield, IL 60015, Product Code 2B0043, NDC 0338-0553-18.
by Baxter Healthcare Corp.
- Reason
- Lack of Assurance of Sterility: potential for leaking containers which lacks the assurance of sterility.
- Published
- June 1, 2016
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass I
LIPO ESCULTURA capsules, 250 mg, 60-count bottles, Distributed By: JAT Productos Naturales Corp., BROOKLYN, NY 11238, www.lipoesculturatreatment.com
by Lipo Escultura Corp.
- Reason
- Marketed Without An Approved NDA/ANDA: Tainted product marketed as a dietary supplement. Product found to be tainted with sibutramine, an appetite suppressant that was withdrawn from the U.S. market in October 2010 for safety reasons, and diclofenac, a prescription non-steroidal anti-inflammatory drug, making this an unapproved drug.
- Published
- June 1, 2016
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass I
Amikacin Sulfate injection USP,1 gm/4 mL (250 mg/mL) 4mL vial, Rx only, Manufactured in Hungary For: Teva Pharmaceuticals USA, INC. North Wales, PA 19454. Individual Pack NDC 0703-9040-01, Shelf Pack NDC 0703-9040-03
by Teva Pharmaceuticals USA
- Reason
- Presence of Particulate Matter: particulate matter identified as glass in one vial.
- Published
- June 1, 2016
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Sclerosol Intrapleural Aerosol (sterile talc powder), Intrapleural administration, 4 g Canister, Rx Only, Distributed by: Bryan Corporation, Woburn, MA 01801, USA, NDC 63256-100-30
by Lymol Medical
- Reason
- Defective Delivery System: Defective stem valve causes leakage of the propellant in the spray canister delivering no drug or an inadequate amount of the drug to be delivered.
- Published
- June 1, 2016
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Zoloft (sertraline HCl) tablets, 100 mg*, 30 count bottles, Rx only, Distributed by Roerig, Division of Pfizer, Inc., NY NY 10017, NDC 0049-4910-30.
by Pfizer Inc.
- Reason
- Failed Tablet/Capsule Specifications: thick tablets exceeding specifications were found.
- Published
- June 1, 2016
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass III
col-rite (docusate sodium) stool softener softgels, 50 mg, packaged in a) 30-count, item 351104, UPC 0 11822 51104 9; and b) 60-count, item 357392, UPC 0 11822 57392 4; DISTRIBUTED BY: RITE AID, 30 HUNTER LANE, CAMP HILL , PA 17011.
by Allegiant Health
- Reason
- Superpotent Drug: High out of specification results for assay at the 6 month time point interval.
- Published
- May 25, 2016
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Renovo Patch (Capsaicin, 0.0375%, Menthol, USP 5.00%), 3-count patches per carton, Rx only, Distributed By: TMIG Inc, Marietta , GA 30062, Manufactured By: Pocono Coated Products LLC., Cherryville, NC 28021 NDC: 69176-025-03
by TMIG Inc
- Reason
- Marketed Without An Approved NDA/ANDA: product is an unapproved drug and additionally 3 lots were found to be subpotent.
- Published
- May 25, 2016
- Distribution
- Nationwide
View recall →
FDA Recall
Ongoing
Historical recordClass III
Magnesium Sulfate Inj., USP 50%, 10 g/20 mL (0.5 g/mL), (4 mEq Magnesium/mL, 20 mL Single-dose vial, packaged in 25 vials per box, Rx Only, Hospira, Inc., Lake Forest, IL 60045, NDC 0409-2168-02, barcode (01) 2 030409 216802 5.
by Hospira Inc.
- Reason
- Failed pH Specifications: Confirmed high out of specification (OOS) results for pH.
- Published
- May 25, 2016
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Brevibloc DOUBLE STRENGTH Premixed Injection, Esmolol Hydrochloride in Sodium Chloride, 2000mg/100mL (20 mg/mL), 100 mL, Rx only, Manufactured by Baxter Healthcare Corporation, Deerfield, Il 60015, NDC 10019-075-87
by Baxter Healthcare Corp.
- Reason
- Discoloration: presence of atypical yellow discoloration of the solution .
- Published
- May 18, 2016
- Distribution
- Nationwide
View recall →
FDA Recall
Ongoing
Historical recordClass II
Screenses Color Sunscreen, Tinted facial make-up compact, Broad Spectrum SPF 50 Light, 0.35 oz (10 g), Manufactured by Sesderma S.L., Valencia, Spain, UPC 8 429979 252159
by Sesderma, SL
- Reason
- cGMP Deviations; product does not comply with cGMP requirements
- Published
- May 18, 2016
- Distribution
- Distributed to following states: FL, PR,…
View recall →
FDA Recall
Ongoing
Historical recordClass II
Screenses Color Sunscreen Tinted facial make-up compact, Broad Spectrum SPF 50, Brown, 0.35 oz (10 g), Manufactured by Sesderma S.L., Valencia, Spain, UPC 8 429979 252166
by Sesderma, SL
- Reason
- cGMP Deviations; product does not comply with cGMP requirements
- Published
- May 18, 2016
- Distribution
- Distributed to following states: FL, PR,…
View recall →
FDA Recall
Ongoing
Historical recordClass II
Repaskin 30 (octacrylene 4%, oxybenzone 3%, octisalate 3%, octinoxate 3% Avobenzone 3%) Facial Sunscreen gel cream, Broad Spectrum SPF 30, 1.7 fl oz (50 mL) bottle, over the counter, Manufactured by Sesderma S.L., Valencia, Spain, NDC 63181-0010-1
by Sesderma, SL
- Reason
- cGMP Deviations; product does not comply with cGMP requirements
- Published
- May 18, 2016
- Distribution
- Distributed to following states: FL, PR,…
View recall →
FDA Recall
Ongoing
Historical recordClass II
Repaskin 50 (octocrylene 7%, titanium oxide 2%) Facial Sunscreen gel cream, Broad Spectrum SPF 50, 1.7 fl oz (50 mL) tube, over the counter, Manufactured by Sesderma S.L., Valencia, Spain, NDC 63181-0011-1
by Sesderma, SL
- Reason
- cGMP Deviations; product does not comply with cGMP requirements
- Published
- May 18, 2016
- Distribution
- Distributed to following states: FL, PR,…
View recall →
FDA Recall
Ongoing
Historical recordClass II
Dryses Aluminum Chlorohydrate Deodorant for Women, Roll-on, 2.5 fl oz (75 mL) bottle, over the counter, Manufactured by Sesderma S.L., Valencia, Spain, NDC 16047-0029-1
by Sesderma, SL
- Reason
- cGMP Deviations; product does not comply with cGMP requirements
- Published
- May 18, 2016
- Distribution
- Distributed to following states: FL, PR,…
View recall →
FDA Recall
Ongoing
Historical recordClass II
Dryses Aluminum Chlorohydrate Deodorant for Men Roll-on, 2.5 fl oz (75 mL) bottle, over the counter, Manufactured by Sesderma S.L., Valencia, Spain, NDC 63181-0019-1 UPC 8 470002 075221
by Sesderma, SL
- Reason
- cGMP Deviations; product does not comply with cGMP requirements
- Published
- May 18, 2016
- Distribution
- Distributed to following states: FL, PR,…
View recall →
FDA Recall
Ongoing
Historical recordClass II
Repaskin 30 (octacrylene 4%, oxybenzone 3%, octisalate 3%, octinoxate 3% Avobenzone 3%) Body Lotion Sunscreen gel cream, Broad Spectrum SPF 30, 6.8 fl oz (200 mL) tube, over the counter, Manufactured by Sesderma S.L., Valencia, Spain, NDC 63181-0012-1 UPC8 429979 415691
by Sesderma, SL
- Reason
- cGMP Deviations; product does not comply with cGMP requirements
- Published
- May 18, 2016
- Distribution
- Distributed to following states: FL, PR,…
View recall →
FDA Recall
Ongoing
Historical recordClass II
Repaskin 50 (octocrylene 7%, titanium dioxide 2%) Body Lotion Sunscreen gel cream, Broad Spectrum SPF 50, 6.8 fl oz (200 mL) tube, over the counter, Manufactured by Sesderma S.L., Valencia, Spain, NDC 63181-0013-1, UPC 8 429979 415707
by Sesderma, SL
- Reason
- cGMP Deviations; product does not comply with cGMP requirements
- Published
- May 18, 2016
- Distribution
- Distributed to following states: FL, PR,…
View recall →
FDA Recall
Ongoing
Historical recordClass II
Salises Facial Moisturizing Acne Treatment Gel, (salicylic acid 1.5%), 1.7 fl. oz (50 mL) bottle, over the counter, Manufactured by Sesderma S.L., Valencia, Spain --- NDC 63181-0016
by Sesderma, SL
- Reason
- cGMP Deviations; product does not comply with cGMP requirements
- Published
- May 18, 2016
- Distribution
- Distributed to following states: FL, PR,…
View recall →
Recall records are summarized from official FDA and USDA sources. Notices may be updated, reclassified, terminated, or withdrawn. Always review the linked official notice for the most current instructions.
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