FDA Recall
TerminatedTerminated: January 18, 2022Historical recordClass III
Evrysdi (risdiplam) for oral solution, 60 mg/80mL (0.75mg/mL), 80 mL total volume after constitution, Rx only, Distributed by: Genentech, Inc. NDC:50242-175-05
by Genentech Inc
- Reason
- Defective Container: complaints received regarding some incorrect press-in-bottle-adapters (PIBA), the incorrect PIBAs have a female instead of male fit so they cannot be used in combination with co-packed syringes.
- Published
- May 5, 2021
- Distribution
- Nationwide
View recall →
FDA Recall
TerminatedTerminated: December 2, 2022Historical recordClass II
Oxygen, Compressed, USP UN 1072, packaged in cylinders labeled as: a) M6 Medical Gas Cylinder, b) C Medical Gas Cylinder; c) D Medical Gas Cylinder; d) E Medical Gas Cylinder; e) M Medical Gas Cylinder; f) H Medical Gas Cylinder, Rx only, Grace Healthcare 1418 31st Avenue Gulfport, MS 39501 228-863-3331
by Grace Healthcare Medical, Inc
- Reason
- cGMP deviations
- Published
- May 5, 2021
- Distribution
- Nationwide
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FDA Recall
OngoingHistorical recordClass II
Triple SupremeZen Gold 3500, Packaged in paper packaging with a pill blister,1 capsule per box, Distributed by VIEW LIFE Distributors Los Angeles CA 90005 UPC 7 15122 05089 4
by Na Na Collection
- Reason
- Marketed without Approved NDA/ANDA: FDA analysis results obtained the presence of tadalafil and/or sildenafil.
- Published
- May 5, 2021
- Distribution
- Nationwide
View recall →
FDA Recall
OngoingHistorical recordClass II
PremierZen Platinum 5000, Packaged in paper packaging with a pill blister, 1 capsule per box, Distributed by New Premier Group Los Angeles CA 90006
by Na Na Collection
- Reason
- Marketed without Approved NDA/ANDA: FDA analysis results obtained the presence of tadalafil and/or sildenafil.
- Published
- May 5, 2021
- Distribution
- Nationwide
View recall →
FDA Recall
OngoingHistorical recordClass II
Imperial Extreme 2000 Capsules, 2000 mg, 1 count blister cards, distributed S&B Shopper LLC. Little Ferry, NJ UPC 7 18122 04073 5
by S & B Story LLC
- Reason
- Marketed without Approved NDA/ANDA: FDA analysis results obtained the presence of tadalafil and sildenafil.
- Published
- May 5, 2021
- Distribution
- Nationwide
View recall →
FDA Recall
TerminatedTerminated: July 16, 2021Historical recordClass II
PremierZen Black 5000 capsules, 1 capsule per card/24 capsules per box, Distributed by New Premier Group Los Angeles CA 90006 UPC 7 2817542189 4
by Namoo Enterprise LLC
- Reason
- Marketed without Approved NDA/ANDA: FDA analysis results obtained the presence of tadalafil and sildenafil.
- Published
- May 5, 2021
- Distribution
- Nationwide
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FDA Recall
TerminatedTerminated: September 29, 2022Historical recordClass II
ChloraPrep With Tint 2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol (IPA) Non-Sterile Solution - Hi-Lite Orange, 0.10 fl. oz. (3 ml) each, 25 applicators in carton, applicator is sterile if package is intact. CareFusion El Paso, TX 79912, NDC 054365-400-11 Cat. No. 260415
by CareFusion 213, LLC
- Reason
- CGMP Deviations: Product is being recalled because at labeled storage conditions of 30*C/75% Relative Humidity, there is the potential for growth of Aspergillus penicillioides, a type of fungus, resulting in a breach of the package integrity.
- Published
- May 5, 2021
- Distribution
- Nationwide
View recall →
FDA Recall
TerminatedTerminated: September 29, 2022Historical recordClass II
ChloraPrep One-Step 2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol (IPA) Non-Sterile Solution -Clear, 0.10 fl. oz. (3ml) each, 25 applicators per carton, applicator is sterile if package is intact. CareFusion El Paso, TX 79912, NDC 054365-400-01 Cat. No. 260400
by CareFusion 213, LLC
- Reason
- CGMP Deviations: Product is being recalled because at labeled storage conditions of 30*C/75% Relative Humidity, there is the potential for growth of Aspergillus penicillioides, a type of fungus, resulting in a breach of the package integrity.
- Published
- May 5, 2021
- Distribution
- Nationwide
View recall →
FDA Recall
TerminatedTerminated: September 29, 2022Historical recordClass II
BD ChloraPrep Hi-Lite Orange 2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol (IPA), Sterile Solution, 0.10 fl. oz. (3 ml) each, 25 Applicators in carton, applicator is sterile if package is intact. CareFusion El Paso, TX 79912, subsidiary of Becton, Dickinson and Co., NDC 54365-400-33 REF 930415
by CareFusion 213, LLC
- Reason
- Lack of Assurance of Sterility: Product is being recalled because at labeled storage conditions of 30*C/75% Relative Humidity, there is the potential for growth of Aspergillus penicillioides, a type of fungus, resulting in a breach of the package integrity.
- Published
- May 5, 2021
- Distribution
- Nationwide
View recall →
FDA Recall
TerminatedTerminated: September 29, 2022Historical recordClass II
BD ChloraPrep Clear, 2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol (IPA) Sterile Solution, 0.10 fl. oz. (3 ml) each, 25 Applicators in carton, applicator is sterile if package is intact. CareFusion 213, LLC, El Paso, TX 79912, subsidiary of Becton, Dickinson and Co, NDC 54365-400-32 REF 930400
by CareFusion 213, LLC
- Reason
- Lack of Assurance of Sterility: Product is being recalled because at labeled storage conditions of 30*C/75% Relative Humidity, there is the potential for growth of Aspergillus penicillioides, a type of fungus, resulting in a breach of the package integrity.
- Published
- May 5, 2021
- Distribution
- Nationwide
View recall →
FDA Recall
TerminatedTerminated: September 29, 2022Historical recordClass I
ChloraPrep With Tint 2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol (IPA) Non-Sterile Solution - Hi-Lite Orange, 0.10 fl. oz. (3 ml) each, 25 applicators in carton, applicator is sterile if package is intact. CareFusion El Paso, TX 79912, NDC 054365-400-11 Cat. No. 260415
by CareFusion 213, LLC
- Reason
- Microbial Contamination of Non-Sterile Product:.Product is being recalled because at labeled storage conditions of 30*C/75% Relative Humidity, growth of Aspergillus penicillioides, a type of fungus, resulted in a breach of the package integrity.
- Published
- May 5, 2021
- Distribution
- Nationwide
View recall →
FDA Recall
TerminatedTerminated: September 29, 2022Historical recordClass I
ChloraPrep One-Step 2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol (IPA) Non-Sterile Solution -Clear, 0.10 fl. oz. (3ml) each, 25 applicators per carton, applicator is sterile if package is intact. CareFusion El Paso, TX 79912, NDC 054365-400-01 Cat. No. 260400
by CareFusion 213, LLC
- Reason
- Microbial Contamination of Non-Sterile Product.Product is being recalled because at labeled storage conditions of 30*C/75% Relative Humidity, growth of Aspergillus penicillioides, a type of fungus, resulted in a breach of the package integrity.
- Published
- May 5, 2021
- Distribution
- Nationwide
View recall →
FDA Recall
TerminatedTerminated: September 29, 2022Historical recordClass I
BD ChloraPrep Hi-Lite Orange 2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol (IPA), Sterile Solution, 0.10 fl. oz. (3 ml) each, 25 Applicators in carton, applicator is sterile if package is intact. CareFusion El Paso, TX 79912, subsidiary of Becton, Dickinson and Co., NDC 54365-400-33 REF 930415
by CareFusion 213, LLC
- Reason
- Non-sterility.Product is being recalled because at labeled storage conditions of 30*C/75% Relative Humidity, growth of Aspergillus penicillioides, a type of fungus, resulted in a breach of the package integrity.
- Published
- May 5, 2021
- Distribution
- Nationwide
View recall →
FDA Recall
TerminatedTerminated: September 29, 2022Historical recordClass I
BD ChloraPrep Clear, 2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol (IPA) Sterile Solution, 0.10 fl. oz. (3 ml) each, 25 Applicators in carton, applicator is sterile if package is intact. CareFusion 213, LLC, El Paso, TX 79912, subsidiary of Becton, Dickinson and Co, NDC 54365-400-32 REF 930400
by CareFusion 213, LLC
- Reason
- Non-sterility.Product is being recalled because at labeled storage conditions of 30*C/75% Relative Humidity, growth of Aspergillus penicillioides, a type of fungus, resulted in a breach of the package integrity.
- Published
- May 5, 2021
- Distribution
- Nationwide
View recall →
FDA Recall
TerminatedTerminated: August 15, 2024Historical recordClass III
Betamethasone Dipropionate Ointment USP, 0.05% (Augmented), packaged in 15 grams tubes, Manufactured by: Teligent Pharma, Inc. Buena, New Jersey 08310, Distributed by: McKesson Corporation dba Sky Packaging 4971 Southbridge Blvd., Suite 101 Memphis, TN 38141, NDC 63739-996-15
by Teligent Pharma, Inc.
- Reason
- Failed Impurities/ Degradation Specifications - OOS for know impurity Betamethasone 17- propionate.
- Published
- May 5, 2021
- Distribution
- Nationwide
View recall →
FDA Recall
TerminatedTerminated: August 15, 2024Historical recordClass III
Betamethasone Dipropionate Ointment USP, 0.05% (Augmented), packaged in 50 grams tubes, Manufactured by: Teligent Pharma, Inc. Buena, New Jersey 08310, NDC 52565-019-51
by Teligent Pharma, Inc.
- Reason
- Failed Impurities/ Degradation Specifications - OOS for know impurity Betamethasone 17- propionate.
- Published
- May 5, 2021
- Distribution
- Nationwide
View recall →
FDA Recall
TerminatedTerminated: August 15, 2024Historical recordClass III
Betamethasone Dipropionate Ointment USP, 0.05% (Augmented), packaged in 15 grams tubes, Manufactured by: Teligent Pharma, Inc. Buena, New Jersey 08310, NDC 52565-019-15
by Teligent Pharma, Inc.
- Reason
- Failed Impurities/ Degradation Specifications - OOS for know impurity Betamethasone 17- propionate.
- Published
- May 5, 2021
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
TerminatedTerminated: December 9, 2021Historical recordClass I
GOLDEN MEDAL MUSHROOM INC
- Product
- Enoki Mushroom Product of Korea Net Wt. 200 g/7.05 oz. UPC:…
- Reason
- Michigan Department of Agriculture and Rural Development sampled product and results found Listeria monocytogenes.
- Published
- May 5, 2021
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
TerminatedTerminated: September 21, 2021Historical recordClass II
Torn & Glasser, Inc.
- Product
- Dark Chocolate Expresso Beans; Net Wt. 12 oz. (340g), Bes…
- Reason
- Dark Chocolate walnuts were packed in a container labeled at Dark Chocolate Espresso Beans and does not declare walnuts as an allergen Bottom label with nutritional information is correct for the Dark Chocolate Walnuts.
- Published
- May 5, 2021
- Distribution
- Alaska, Alabama, Arizona, Arkansas, Cali…
View recall →
FDA Recall
OngoingHistorical recordClass II
Flurandrenolide Ointment USP, 0.05%, Net Wt. 60 grams, Rx Only, Teligent Pharma, Inc. Buena, New Jersey 08310 NDC 52565-017-60
by Teligent Pharma, Inc.
- Reason
- Failed Impurities/Degradation Specifications:
- Published
- April 28, 2021
- 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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