FDA Recall
TerminatedTerminated: April 23, 2018Historical recordClass II
Methylcobalamin 5000 mcg/mL Injectable, 2 mL vial, Rx only, Liberty Drug Compound Center, 195 Main St., PO Box 267, Chatham, NJ 07928.
by Liberty Drug & Surgical
- Reason
- Lack of Assurance of Sterility: Process deficiencies were observed in the sterile ophthalmic and injectable products that could have compromised the sterility of the product.
- Published
- September 2, 2015
- Distribution
- Physicians, Medical Facilities, and Pres…
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FDA Recall
TerminatedTerminated: April 23, 2018Historical recordClass II
Papaverine/Phentolamine/PGE-1 Injectable, 30 mg/1 mg/10 mcg/mL, 2.5 mL vial, Rx only, Liberty Drug Compound Center, 195 Main St., PO Box 267, Chatham, NJ 07928.
by Liberty Drug & Surgical
- Reason
- Lack of Assurance of Sterility: Process deficiencies were observed in the sterile ophthalmic and injectable products that could have compromised the sterility of the product.
- Published
- September 2, 2015
- Distribution
- Physicians, Medical Facilities, and Pres…
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FDA Recall
TerminatedTerminated: April 23, 2018Historical recordClass II
Cyanocobalamin 500 mcg/mL Injectable, 1 mL pre-filled syringe, Rx only, Liberty Drug Compound Center, 195 Main St., PO Box 267, Chatham, NJ 07928.
by Liberty Drug & Surgical
- Reason
- Lack of Assurance of Sterility: Process deficiencies were observed in the sterile ophthalmic and injectable products that could have compromised the sterility of the product.
- Published
- September 2, 2015
- Distribution
- Physicians, Medical Facilities, and Pres…
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FDA Recall
TerminatedTerminated: December 15, 2016Historical recordClass III
Amlodipine besylate and Atorvastatin calcium Tablets, 10 mg/80 mg, 30 Count Bottles, Rx Only. Manufactured by Dr. Reddy's Laboratories Limited, Bachupally - 500 090 India. NDC: 43598-313-30.
by Dr. Reddy's Laboratories, Inc.
- Reason
- Subpotent Drug: Subpotent atorvastatin.
- Published
- September 2, 2015
- Distribution
- Nationwide
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FDA Recall
TerminatedTerminated: December 15, 2016Historical recordClass III
Amlodipine besylate and Atorvastatin calcium Tablets,10 mg/40 mg, Packaged in a) 30 Count Bottles (NDC: 43598-315-30) and b) 90 Count Bottles (NDC: 43598-315-90), Rx Only. Manufactured by Dr. Reddy's Laboratories Limited, Bachupally - 500 090 India.
by Dr. Reddy's Laboratories, Inc.
- Reason
- Subpotent Drug: Subpotent atorvastatin.
- Published
- September 2, 2015
- Distribution
- Nationwide
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FDA Recall
TerminatedTerminated: December 15, 2016Historical recordClass III
Amlodipine besylate and Atorvastatin calcium Tablets, 10 mg/20 mg, Packaged in a) 30 Count Bottles (NDC: 43598-318-30) and b) 90 Count Bottles (NDC: 43598-318-90), Rx Only. Manufactured by Dr. Reddy's Laboratories Limited, Bachupally - 500 090 India
by Dr. Reddy's Laboratories, Inc.
- Reason
- Subpotent Drug: Subpotent atorvastatin.
- Published
- September 2, 2015
- Distribution
- Nationwide
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FDA Recall
TerminatedTerminated: December 15, 2016Historical recordClass III
Amlodipine besylate and Atorvastatin calcium Tablets, 5 mg/20 mg, Packaged in a) 30 Count Bottles (NDC: 43598-319-30) and b) 90 Count Bottles (NDC: 43598-319-90), Rx Only. Manufactured by Dr. Reddy's Laboratories Limited, Bachupally - 500 090 India.
by Dr. Reddy's Laboratories, Inc.
- Reason
- Subpotent Drug: Subpotent atorvastatin.
- Published
- September 2, 2015
- Distribution
- Nationwide
View recall →
FDA Recall
TerminatedTerminated: December 15, 2016Historical recordClass III
Amlodipine besylate and Atorvastatin calcium Tablets,2.5 mg/40 mg, 30 Count Bottles, Rx Only. Manufactured by Dr. Reddy's Laboratories Limited, Bachupally - 500 090 India. NDC: 43598-317-30.
by Dr. Reddy's Laboratories, Inc.
- Reason
- Subpotent Drug: Subpotent atorvastatin.
- Published
- September 2, 2015
- Distribution
- Nationwide
View recall →
FDA Recall
TerminatedTerminated: December 15, 2016Historical recordClass III
Amlodipine besylate and Atorvastatin calcium Tablets, 2.5 mg/20 mg, 30 Count Bottles, Rx Only. Manufactured by Dr. Reddy's Laboratories Limited, Bachupally - 500 090 India. NDC: 43598-320-30.
by Dr. Reddy's Laboratories, Inc.
- Reason
- Subpotent Drug: Subpotent atorvastatin.
- Published
- September 2, 2015
- Distribution
- Nationwide
View recall →
FDA Recall
TerminatedTerminated: December 15, 2016Historical recordClass III
Amlodipine besylate and Atorvastatin calcium Tablets, 2.5 mg/10 mg, 30 Count Bottles, Rx Only. Manufactured by Dr. Reddy's Laboratories Limited, Bachupally - 500 090 India. NDC: 43598-323-30.
by Dr. Reddy's Laboratories, Inc.
- Reason
- Subpotent Drug: Subpotent atorvastatin.
- Published
- September 2, 2015
- Distribution
- Nationwide
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FDA Recall
TerminatedTerminated: January 13, 2017Historical recordClass III
Phentermine Hydrochloride Capsules, USP, 15 mg, packaged in a) 100-count bottle (NDC 10702-0026-01; UPC 3 10702 02601 8) and b) 1000-count bottle (NDC 10702-0026-10; UPC 3 10702 02601 0); Rx only, Mfd. by KVK-TECH, Inc., Newtown, PA
by KVK-Tech, Inc.
- Reason
- Failed Impurities/Degradation Specifications: out-of-specification results for individual unknown and total impurity at the 12th month room temperature stability test station
- Published
- September 2, 2015
- Distribution
- Nationwide
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FDA Recall
TerminatedTerminated: April 3, 2017Historical recordClass III
Topicort (desoximetasone) Topical Spray, 0.25%, 100 mL Bottles, Rx Only. Mfd by: Taro Pharmaceuticals, Inc., Brampton, Ontario, Canada, L6T 1C1, Dist by: TaroPharma, Hawthorne, NY 10532. NDC: 51672-5281-7.
by Taro Pharmaceuticals, Inc.
- Reason
- Failed Impurities/Degradation Specifications: Out of specification results for impurities testing was obtained at the 6 and 9 month time points.
- Published
- September 2, 2015
- Distribution
- Nationwide
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FDA Recall
TerminatedTerminated: March 9, 2018Historical recordClass II
Mucinex Fast Max DM Max, Maximum Strength, Dextromethorphan HBr Cough Suppressant, 6 fl oz (180 mL) Bottle, For Ages 12+, Dist. By: Reckitt Benckiser Parsippany, NJ 07054-0224 Made in India, NDC 63824-019-66, UPC 63824-01966-9, UPC 63824-52622-5
by Reckitt Benckiser LLC
- Reason
- Labeling: Label Mix-Up; Bottles of Mucinex Fast-Max liquid are correctly labeled on the front of the label, however the back of the bottle where the Drug Facts labeling is, is missing certain Active Ingredients such as acetaminophen, phenylephrine, dextromethorphan, diphenhydramine, and/or guaifenesin. As a result certain safety warnings associated with those ingredients may also be missing.
- Published
- September 2, 2015
- Distribution
- Nationwide
View recall →
FDA Recall
TerminatedTerminated: March 9, 2018Historical recordClass I
Mucinex Fast Max Day Time Severe Congestion & Cough Night Time Cold & Flu, Maximum Strength, Two - 6 fl oz (180 mL) bottles Total - 12 fl oz (360 mL), For Ages 12+, Dist. by Reckitt Benckiser Parsippany, NJ 07054-0224, Made in India, NDC 63824-528-22-01, NDC 63824-528-22-00, UPC 63824-52822-9
by Reckitt Benckiser LLC
- Reason
- Labeling: Label Mix-Up; Bottles of Mucinex Fast-Max liquid are correctly labeled on the front of the label, however the back of the bottle where the Drug Facts labeling is, is missing certain Active Ingredients such as acetaminophen, phenylephrine, dextromethorphan, diphenhydramine, and/or guaifenesin. As a result certain safety warnings associated with those ingredients may also be missing.
- Published
- September 2, 2015
- Distribution
- Nationwide
View recall →
FDA Recall
TerminatedTerminated: March 9, 2018Historical recordClass I
Mucinex Fast Max Severe Congestion & Cough, Maximum Strength, Dextromethorphan HBr Cough Suppressant, Guaifenesin Expectorant, Phenylephrine HCl Nasal Decongestant, 6 fl oz (180 mL) Bottle, For Age 12+, Dist. By: Reckitt Benckiser Parsippany, NJ 07054-0224, Made in India, NDC 63824-014-66, UPC 6382401465-4
by Reckitt Benckiser LLC
- Reason
- Labeling: Label Mix-Up; Bottles of Mucinex Fast-Max liquid are correctly labeled on the front of the label, however the back of the bottle where the Drug Facts labeling is, is missing certain Active Ingredients such as acetaminophen, phenylephrine, dextromethorphan, diphenhydramine, and/or guaifenesin. As a result certain safety warnings associated with those ingredients may also be missing.
- Published
- September 2, 2015
- Distribution
- Nationwide
View recall →
FDA Recall
TerminatedTerminated: March 9, 2018Historical recordClass I
Mucinex Fast Max Day Time Severe Cold and Fast-Max Night Time Cold & Flu Two - 6 fl oz (180 mL) bottles Total -12 fl oz (360 mL), For Age 12+, Dist. By: Reckitt Benckiser Parsippany, NJ 07054-0224 Made in India, NDC 63824-526-22
by Reckitt Benckiser LLC
- Reason
- Labeling: Label Mix-Up; Bottles of Mucinex Fast-Max liquid are correctly labeled on the front of the label, however the back of the bottle where the Drug Facts labeling is, is missing certain Active Ingredients such as acetaminophen, phenylephrine, dextromethorphan, diphenhydramine, and/or guaifenesin. As a result certain safety warnings associated with those ingredients may also be missing.
- Published
- September 2, 2015
- Distribution
- Nationwide
View recall →
FDA Recall
TerminatedTerminated: March 9, 2018Historical recordClass I
Mucinex Fast-Max Cold & Sinus, Maximum Strength, Acetaminophen Pain Reliever/Fever Reducer, Guaifenesin Expectorant, Phenylephrine HCl Nasal Decongestant, 6 fl oz (180 mL) Bottle, For Ages 12+, Dist. by: Reckitt Benckiser Parsippany, NJ 07054-0224 Made in India, NDC 63824-016-66, UPC 63824-01665-8
by Reckitt Benckiser LLC
- Reason
- Labeling: Label Mix-Up; Bottles of Mucinex Fast-Max liquid are correctly labeled on the front of the label, however the back of the bottle where the Drug Facts labeling is, is missing certain Active Ingredients such as acetaminophen, phenylephrine, dextromethorphan, diphenhydramine, and/or guaifenesin. As a result certain safety warnings associated with those ingredients may also be missing.
- Published
- September 2, 2015
- Distribution
- Nationwide
View recall →
FDA Recall
TerminatedTerminated: March 9, 2018Historical recordClass I
Mucinex Fast Max Night Time Cold & Flu, Maximum Strength, Acetaminophen Pain Reliever/Fever Reducer, Diphenhydramine HCl Antihistamine/Cough Suppressant, Phenylephrine HCl Nasal Decongestant, 6 fl oz. (180 mL) Bottle, For Ages 12+, Dist. By: Reckitt Benckiser Parsippany, NJ 07054-0224 Made in India, NDC 63824-500-66, UPC 63824-50066-09
by Reckitt Benckiser LLC
- Reason
- Labeling: Label Mix-Up; Bottles of Mucinex Fast-Max liquid are correctly labeled on the front of the label, however the back of the bottle where the Drug Facts labeling is, is missing certain Active Ingredients such as acetaminophen, phenylephrine, dextromethorphan, diphenhydramine, and/or guaifenesin. As a result certain safety warnings associated with those ingredients may also be missing.
- Published
- September 2, 2015
- Distribution
- Nationwide
View recall →
FDA Recall
TerminatedTerminated: March 9, 2018Historical recordClass I
Mucinex Fast Max Cold, Flu & Sore Throat, Maximum Strength, Acetaminophen Pain Reliever/Fever Reducer, Dextromethorphan HBr Cough Suppressant, Guaifenesin Expectorant, Phenylephrine HCl Nasal Decongestant, 6 fl oz (180 mL) Bottle, For Ages 12+, , Dist. By: Reckitt Benckiser Parsippany, NJ 07054-0224 Made in India, NDC 63824-015-66, UPC 63824-01565-1
by Reckitt Benckiser LLC
- Reason
- Labeling: Label Mix-Up; Bottles of Mucinex Fast-Max liquid are correctly labeled on the front of the label, however the back of the bottle where the Drug Facts labeling is, is missing certain Active Ingredients such as acetaminophen, phenylephrine, dextromethorphan, diphenhydramine, and/or guaifenesin. As a result certain safety warnings associated with those ingredients may also be missing.
- Published
- September 2, 2015
- Distribution
- Nationwide
View recall →
FDA Recall
TerminatedTerminated: March 21, 2017Historical recordClass II
Mupirocin Calcium Cream, 2%, a) 15g tube (NDC 66993-942-15),b) 30g tube (NDC 66993-942-31), Rx only, Manufactured by Glaxo Operations UK Ltd, Harmire Road, Barnard Castle, UK for GlaxoSmithKline PO Box 1217 Zebulon, NC 27597-1217.
by GlaxoSmithKline, LLC.
- Reason
- Penicillin Cross Contamination and Presence of Foreign Substance. Product was contaminated with penicillin and foreign substances during manufacturing process.
- Published
- September 2, 2015
- 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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