FDA Recall
Terminated
Historical recordClass II
0.9% Sodium Chloride Injection USP, 100 mL Viaflex Container, Rx Only, Baxter Healthcare Corporation, Deerfield, IL 60015, USA, NDC 0338-0049-38.
by Baxter Healthcare Corporation
- Reason
- Lack of Assurance of Sterility: Bags have potential to leak.
- Published
- July 31, 2019
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Temozolomide Capsules, 250 mg, 5-count bottle, Rx only, Manufactured by: Deva Holding A.S., 1 Merkez Mahallesi, Istanbul, Turkey 34303, Distributed by: Ascend Laboratories, LLC, Parsippany, NJ 07054, NDC 67877-542-07.
by Deva Holding AS - Cerkezkoy Subesi
- Reason
- CGMP Deviations: product was manufactured that did not prevent possible cross contamination with beta lactam products.
- Published
- July 31, 2019
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Temozolomide Capsules, 180 mg, packaged in a) 5-count bottle (NDC 67877-541-07), b) 14-count bottle (NDC 67877-541-14), Rx only, Manufactured by: Deva Holding A.S., 1 Merkez Mahallesi, Istanbul, Turkey 34303, Distributed by: Ascend Laboratories, LLC, Parsippany, NJ 07054.
by Deva Holding AS - Cerkezkoy Subesi
- Reason
- CGMP Deviations: product was manufactured that did not prevent possible cross contamination with beta lactam products.
- Published
- July 31, 2019
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Temozolomide Capsules, 140 mg, packaged in a) 5-count bottle (NDC 67877-540-07), b) 14-count bottle (NDC 67877-540-14), Rx only, Manufactured by: Deva Holding A.S., 1 Merkez Mahallesi, Istanbul, Turkey 34303, Distributed by: Ascend Laboratories, LLC, Parsippany, NJ 07054.
by Deva Holding AS - Cerkezkoy Subesi
- Reason
- CGMP Deviations: product was manufactured that did not prevent possible cross contamination with beta lactam products.
- Published
- July 31, 2019
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Temozolomide Capsules, 100 mg, packaged in a) 5-count bottle (NDC 67877-539-07), b) 14-count bottle (NDC 67877-539-14), Rx only, Manufactured by: Deva Holding A.S., 1 Merkez Mahallesi, Istanbul, Turkey 34303, Distributed by: Ascend Laboratories, LLC, Parsippany, NJ 07054.
by Deva Holding AS - Cerkezkoy Subesi
- Reason
- CGMP Deviations: product was manufactured that did not prevent possible cross contamination with beta lactam products.
- Published
- July 31, 2019
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Temozolomide Capsules, 20 mg, packaged in a) 5-count bottle (NDC 67877-538-07), b) 14-count bottle (NDC 67877-538-14), Rx only, Manufactured by: Deva Holding A.S., 1 Merkez Mahallesi, Istanbul, Turkey 34303, Distributed by: Ascend Laboratories, LLC, Parsippany, NJ 07054.
by Deva Holding AS - Cerkezkoy Subesi
- Reason
- CGMP Deviations: product was manufactured that did not prevent possible cross contamination with beta lactam products.
- Published
- July 31, 2019
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Temozolomide Capsules, 5 mg, packaged in a) 5-count bottle (NDC 67877-537-07), b) 14-count bottle (NDC 67877-537-14), Rx only, Manufactured by: Deva Holding A.S., 1 Merkez Mahallesi, Istanbul, Turkey 34303, Distributed by: Ascend Laboratories, LLC, Parsippany, NJ 07054.
by Deva Holding AS - Cerkezkoy Subesi
- Reason
- CGMP Deviations: product was manufactured that did not prevent possible cross contamination with beta lactam products.
- Published
- July 31, 2019
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Workvie Instant Pain Relieving Roll On (Lidocaine HCL 4% + Menthol 1% & Arnica), 2.5oz (71 g) roll on bottle, Exclusively Distributed by: Marketite, LLC., Coral Gables, FL 33134, NDC 72393-201-25.
by Pharma-Natural Inc.
- Reason
- CGMP Deviations: products were manufactured with lack of process validation, cleaning validation, stability studies, and other current good manufacturing practice violations.
- Published
- July 31, 2019
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
NEOGEN-D (Dextromethorphan HBr, 30 mg; Guaifenesin, 200 mg; Phenylephrine HCl, 7.5 mg) in each 5 mL tsp, Raspberry Flavor, 16 fl oz (473 mL) bottle, Manufactured in the USA for Kramer Novis, San Juan, PR 00917, NDC 52083-699-16.
by Pharma-Natural Inc.
- Reason
- CGMP Deviations: products were manufactured with lack of process validation, cleaning validation, stability studies, and other current good manufacturing practice violations.
- Published
- July 31, 2019
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
SORBUGEN NR (Dextromethorphan HBr, 15 mg; Glyceryl Guaiacolate (Guaifenesin), 150 mg) in each 7.5 mL 1 1/2 tsp), GRAPE FLAVOR, 16 Fl.oz. (473 mL) bottle, Manufactured in the USA for Kramer Novis, San Juan, PR 00917, NDC 52083-660-16.
by Pharma-Natural Inc.
- Reason
- CGMP Deviations: products were manufactured with lack of process validation, cleaning validation, stability studies, and other current good manufacturing practice violations.
- Published
- July 31, 2019
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
TUSSLIN (Dextromethorphan HBr, 28 mg; Guaifenesin, 388 mg; Phenylephrine HCl, 10 mg) in each 5 mL tsp, Grape Flavor, 16 Fl.oz. (474 mL) bottle, Kramer Novis, San Juan, PR 00917, NDC 52083-622-16.
by Pharma-Natural Inc.
- Reason
- CGMP Deviations: products were manufactured with lack of process validation, cleaning validation, stability studies, and other current good manufacturing practice violations.
- Published
- July 31, 2019
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Dayma SUPER FORTE XL10 (Camphor 0.5%, Menthol 2%, Methyl Salicylate 2%) Pain Relieving Topical Analgesic Gel, 4 Oz (113.4 g) jar, Distributed by: Biosfera International Distribution, LLC., Miami Lakes, FL 33016, NDC 63788-118-04.
by Pharma-Natural Inc.
- Reason
- CGMP Deviations: products were manufactured with lack of process validation, cleaning validation, stability studies, and other current good manufacturing practice violations.
- Published
- July 31, 2019
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Lid O Creme (Lidocaine HCL 4% and Menthol 1%) Topical Analgesic Cream, 2.5 Oz (71 g) roll on bottle, Manufactured & Distributed by: Pharma Natural, Inc. Hialeah, FL 33016, NDC 63788-111-25.
by Pharma-Natural Inc.
- Reason
- CGMP Deviations: products were manufactured with lack of process validation, cleaning validation, stability studies, and other current good manufacturing practice violations.
- Published
- July 31, 2019
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Lido E.R. (Lidocaine HCL 4%) Pain Relieving Topical Analgesic Cream, 4 oz (113 g) jar, Distributed by Diabetic Supply of Suncoast, Inc., P.O. Box 2102, Vega Alta, PR 00692, NDC 63788-115-04.
by Pharma-Natural Inc.
- Reason
- CGMP Deviations: products were manufactured with lack of process validation, cleaning validation, stability studies, and other current good manufacturing practice violations.
- Published
- July 31, 2019
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Dermanak original crema blanqueador (Hydroquinone 2%) Skin Fade Cream, 2 OZ. (56.7 g) jar, Manufactured by: Pamby Distributors, Inc., Miami, FL 33126, NDC 63788-108-02.
by Pharma-Natural Inc.
- Reason
- CGMP Deviations: products were manufactured with lack of process validation, cleaning validation, stability studies, and other current good manufacturing practice violations.
- Published
- July 31, 2019
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
LidoAID (Lidocaine HCL 4%) portable pain relieving TOPICAL ANALGESIC GEL, 0.17 Oz (4 g) roll on bottle, Distributed by: Diabetic Supply of Suncoast, Inc., dba Advocate Diabetes, PO Box 2102, Vega Alta, PR 00692, NDC 63788-114-04.
by Pharma-Natural Inc.
- Reason
- CGMP Deviations: products were manufactured with lack of process validation, cleaning validation, stability studies, and other current good manufacturing practice violations.
- Published
- July 31, 2019
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
DOUBLE TUSSIN DM (Dextromethorphan Hbr 20 mg, Guaifenesin 300 mg) in each 5ml teaspoon, 4 FL OZ (120 mL) bottle, Distributed by: Pamby Dist., Miami, FL 33414, NDC 63708-121-04.
by Pharma-Natural Inc.
- Reason
- CGMP Deviations: products were manufactured with lack of process validation, cleaning validation, stability studies, and other current good manufacturing practice violations.
- Published
- July 31, 2019
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
GENCONTUSS (Chlorpheniramine Maleate, 2mg; Dextromethorphan HBr, 10 mg; Phenylephrine HCl, 5 mg) in each 5 mL tsp, Cherry Flavor, 16 fl oz (474 mL) bottle, Manufactured in the USA for Kramer Novis, San Juan, PR 00917, NDC 52083-650-16.
by Pharma-Natural Inc.
- Reason
- CGMP Deviations: products were manufactured with lack of process validation, cleaning validation, stability studies, and other current good manufacturing practice violations.
- Published
- July 31, 2019
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
ARMY HEALTH Pain Reliever Gel With CURCUMIN (Menthol 3.00%), 0.5 OZ jar, Manufactured exclusively for: Manufactured exclusively for: Crossover Telecom, LLC., P.O. Box 520248, Miami, FL 33122, UPC 8 50993 00461 1.
by Pharma-Natural Inc.
- Reason
- CGMP Deviations: products were manufactured with lack of process validation, cleaning validation, stability studies, and other current good manufacturing practice violations.
- Published
- July 31, 2019
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Oliver's Harvest CBD+Lidocaine HCL 4% Pain Relief (Lidocaine HCL 4%) Topical Analgesic Cream, 4 OZ (113.4 g) bottle with pump, Distributed by: Coast to Coast Natural, Inc., Wellington, FL 33414, NDC 63766-119-04.
by Pharma-Natural Inc.
- Reason
- CGMP Deviations: products were manufactured with lack of process validation, cleaning validation, stability studies, and other current good manufacturing practice violations.
- Published
- July 31, 2019
- Distribution
- Nationwide
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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