FDA Recall
TerminatedTerminated: October 27, 2021Historical 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
TerminatedTerminated: October 27, 2021Historical 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
TerminatedTerminated: October 27, 2021Historical 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
TerminatedTerminated: October 27, 2021Historical 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
TerminatedTerminated: October 27, 2021Historical 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
TerminatedTerminated: October 27, 2021Historical 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 →
FDA Recall
TerminatedTerminated: October 27, 2021Historical recordClass II
ARMY HEALTH With CURCUMIN (Menthol 3.00%) Pain Reliever Roll-On, 2.5 FL OZ (73ML) roll on bottle, Manufactured exclusively for: Crossover Telecom, LLC., P.O. Box 520248, Miami, FL 33122, UPC 8 50993 00408 6.
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
TerminatedTerminated: October 27, 2021Historical recordClass II
AbeeMed cream (Menthol 1.48% and Histamine DHCL 0.05%), 2 OZ jar, Manufactured exclusively for: Cas, P.O. Box 520248, Miami, FL 33152, UPC 8 50993 00402 4.
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
TerminatedTerminated: October 27, 2021Historical recordClass II
Oliver's Harvest CBD+Capsaicin 0.2% Pain Relief (Capsaicin 0.2%) Topical Analgesic Cream, 4 OZ (113.4 g) bottle with pump, Distributed by: Coast to Coast Natural, Inc., Wellington, FL 33414, NDC 63788-120-04.
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
🇺🇸 United States
TerminatedTerminated: April 27, 2022Historical recordClass I
Probar LLC
- Product
- PROBAR MEAL Wholeberry Blast, Net Wt. 3oz.(85g), Film wrapp…
- Reason
- Chocolate chip containing meal bars potentially contain undeclared milk and soy
- Published
- July 31, 2019
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
TerminatedTerminated: April 29, 2020Historical recordClass I
The Crystal Spoon Corp.
- Product
- Top Chef Meals Grilled Bison Burger best used by date betwe…
- Reason
- Product may be contaminated with E.coli
- Published
- July 31, 2019
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
TerminatedTerminated: April 27, 2022Historical recordClass I
Probar LLC
- Product
- PROBAR MEAL Peanut Butter Chocolate Chip, Net Wt. 3oz.(85g)…
- Reason
- Chocolate chip containing meal bars potentially contain undeclared milk and soy
- Published
- July 31, 2019
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
TerminatedTerminated: April 27, 2022Historical recordClass I
Probar LLC
- Product
- PROBAR MEAL Original Trail Mix, Net Wt. 3oz. (85g), Film wra…
- Reason
- Chocolate chip containing meal bars potentially contain undeclared milk and soy
- Published
- July 31, 2019
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
TerminatedTerminated: April 27, 2022Historical recordClass I
Probar LLC
- Product
- PROBAR MEAL Chocolate Coconut, Net Wt. 3oz.(85g), Film wrap…
- Reason
- Chocolate chip containing meal bars potentially contain undeclared milk and soy
- Published
- July 31, 2019
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
TerminatedTerminated: September 3, 2019Historical recordClass II
Jelly Belly
- Product
- Jelly Belly Licorice Bridge Mix. Net Wt. 9 oz. (85g); 12 i…
- Reason
- Confectionary bag states Gluten Free, while the ingredient statement lists wheat flour.
- Published
- July 31, 2019
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
TerminatedTerminated: April 27, 2022Historical recordClass I
Probar LLC
- Product
- PROBAR The Simply Real Bar: Chocolate Coconut, Net Wt. 85g,…
- Reason
- Chocolate chip containing meal bars potentially contain undeclared milk and soy
- Published
- July 31, 2019
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
TerminatedTerminated: April 27, 2022Historical recordClass I
Probar LLC
- Product
- PROBAR MEAL Superfood Slam, Net Wt. 3oz.(85g), Film wrapped…
- Reason
- Chocolate chip containing meal bars potentially contain undeclared milk and soy
- Published
- July 31, 2019
- Distribution
- Nationwide
View recall →
FDA Recall
TerminatedTerminated: September 9, 2020Historical recordClass III
Gatifloxacin Ophthalmic Solution 0.5%, For Use in the Eyes Only, Rx Only, Sterile, 2.5 mL Bottle, Manufactured for: Lupin Pharmaceuticals, Inc. Baltimore, Maryland 21202, United States, Manufactured by: Lupin Limited, Pithampur (M.P.) 454 775, India, NDC 68180-435-01.
by Lupin Pharmaceuticals Inc.
- Reason
- Labeling: Missing label; Product complaints reported missing bottle label.
- Published
- July 24, 2019
- Distribution
- Nationwide
View recall →
FDA Recall
TerminatedTerminated: September 20, 2022Historical recordClass I
Fluorouracil Injection, USP, 5 g / 100 mL (50 mg / mL), 100 mL fill in a 100 mL vial, Rx Only, Mfd. by: Fresenius Kabi, Lake Zurich, IL 60047. 63323-117-61 [Fresenius Kabi brand] and NDC 63323-117-69 [NOVAPLUS brand]
by Fresenius Kabi USA, LLC
- Reason
- Presence of Particulate Matter; glass particulates
- Published
- July 24, 2019
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
TerminatedTerminated: September 28, 2020Historical recordClass I
ADM - CHICAGO
- Product
- Gold Medal Flour Mt Bulk Product Code 805046
- Reason
- potential presence of E. coli. O26
- Published
- July 24, 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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