FDA Recall
TerminatedTerminated: January 23, 2017Historical recordClass I
EDGE Amplified Weight Release capsules, 400 mg, 60-count bottle, Developed by Signature, 1027 Highway 70 W, Suite 227, Garner, NC 27529, UPC 8 52175 00417 4.
by Detox Transforms
- Reason
- Marketed Without An Approved NDA/ANDA: Product was found to contain undeclared phenolphthalein and fluoxetine, making EDGE an unapproved drug.
- Published
- May 13, 2015
- Distribution
- Nationwide
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FDA Recall
TerminatedTerminated: June 9, 2016Historical recordClass I
0.9% Sodium Chloride Injection, USP, 250 mL, Rx only, VisIV Container, Hospira, Inc., Lake Forest, IL 60045, NDC 0409-7983-25.
by Hospira Inc.
- Reason
- Presence of Particulate Matter: Confirmed finding of human hair floating in IV solution.
- Published
- May 13, 2015
- Distribution
- Nationwide
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FDA Recall
TerminatedTerminated: December 14, 2017Historical recordClass II
Captopril Tablets, USP 12.5 mg, Rx Only, a) 100 count bottles NDC 64679-902-01, b) 1000 count bottles NDC 64679-902-02, Manufactured by Wockhardt Limited, Mumbai, India, Distributed by: Wockhardt USA LLC., 20 Waterview Boulevard, Parsippany, NJ 07054 USA
by Wockhardt Usa Inc.
- Reason
- Failed Tablet/Capsule Specifications: out of specification for thickness.
- Published
- May 13, 2015
- Distribution
- Nationwide
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FDA Recall
TerminatedTerminated: December 4, 2017Historical recordClass II
Ketorolac Tromethamine Inj. USP, 60 mg (30 mg/mL), 2 mL Fill, Single-dose vial, Rx Only, Hospira Inc., Lake Forest, IL --- NDC 00409-3796-01 --- Also labeled under NOVAPLUS label NDC 00409-3796-49
by Hospira Inc.
- Reason
- Crystallization
- Published
- May 6, 2015
- Distribution
- Nationwide
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FDA Recall
TerminatedTerminated: December 4, 2017Historical recordClass II
Ketorolac Tromethamine Inj. USP, 30 mg (30 mg/mL), 1 mL Fill, Single-dose vial, Rx Only, Hospira Inc., Lake Forest, IL --- NDC 00409-3795-01--- Also labeled under NOVAPLUS label NDC 00409-3795-49
by Hospira Inc.
- Reason
- Crystallization
- Published
- May 6, 2015
- Distribution
- Nationwide
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FDA Recall
TerminatedTerminated: October 27, 2016Historical recordClass II
Fluoxetine Capsules USP, 20 mg, packaged in a) 500-count bottles (NDC 50111-648-02), and (b) 1000- count bottles (NDC 50111-648-03), Rx only, Manufactured by Pliva Krakow Pharmaceutical Company S.A., Krakow, Poland; Manufactured for Teva Pharmaceuticals USA, Sellersville, PA 18960
by Teva Pharmaceuticals USA
- Reason
- Chemical Contamination: Product recalled due to an elevated level of a residual solvent impurity in the API that exceeds the Threshold of Toxicological Concern (TTC) calculation for the impurity.
- Published
- May 6, 2015
- Distribution
- Nationwide
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FDA Recall
TerminatedTerminated: October 27, 2016Historical recordClass II
Fluoxetine Capsules USP, 10 mg, in 100-count bottles, Rx only, Manufactured by Pliva Krakow Pharmaceutical Company S.A., Krakow, Poland, Manufactured for Teva Pharmaceuticals USA, Sellersville, PA 18960. NDC 50111-647-01
by Teva Pharmaceuticals USA
- Reason
- Chemical Contamination: Product recalled due to an elevated level of a residual solvent impurity in the API that exceeds the Threshold of Toxicological Concern (TTC) calculation for the impurity.
- Published
- May 6, 2015
- Distribution
- Nationwide
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FDA Recall
TerminatedTerminated: March 3, 2017Historical recordClass II
Well at Walgreens Regular Strength Comfort Gel Cherry Flavor, 12 fl oz (355 mL)
by Tarmac Products, Inc.
- Reason
- Products failed the Antimicrobial Effectiveness Test
- Published
- April 29, 2015
- Distribution
- Nationwide
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FDA Recall
TerminatedTerminated: October 7, 2015Historical recordClass II
Zolmitriptan active pharmaceutical ingredient packaged in varying grams or kg in bags or drums, Attix Pharmaceuticals, 184 Front Street East, Unit 801, Toronto, Ontario M5A 4N3, Canada
by Attix Pharmaceuticals
- Reason
- Penicillin Cross Contamination: All lots of all products repackaged and distributed between 01/05/12 and 02/12/15 are being recalled because they were repackaged in a facility with penicillin products without adequate separation which could introduce the potential for cross contamination with penicillin.
- Published
- April 29, 2015
- Distribution
- Nationwide
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FDA Recall
TerminatedTerminated: October 7, 2015Historical recordClass II
Zidovudine active pharmaceutical ingredient packaged in varying grams or kg in bags or drums, Attix Pharmaceuticals, 184 Front Street East, Unit 801, Toronto, Ontario M5A 4N3, Canada
by Attix Pharmaceuticals
- Reason
- Penicillin Cross Contamination: All lots of all products repackaged and distributed between 01/05/12 and 02/12/15 are being recalled because they were repackaged in a facility with penicillin products without adequate separation which could introduce the potential for cross contamination with penicillin.
- Published
- April 29, 2015
- Distribution
- Nationwide
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FDA Recall
TerminatedTerminated: October 7, 2015Historical recordClass II
Vardenafil HCl Trihydrate active pharmaceutical ingredient packaged in varying grams or kg in bags or drums, Attix Pharmaceuticals, 184 Front Street East, Unit 801, Toronto, Ontario M5A 4N3, Canada
by Attix Pharmaceuticals
- Reason
- Penicillin Cross Contamination: All lots of all products repackaged and distributed between 01/05/12 and 02/12/15 are being recalled because they were repackaged in a facility with penicillin products without adequate separation which could introduce the potential for cross contamination with penicillin.
- Published
- April 29, 2015
- Distribution
- Nationwide
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FDA Recall
TerminatedTerminated: October 7, 2015Historical recordClass II
Vancomycin HCl active pharmaceutical ingredient packaged in varying grams or kg in bags or drums, Attix Pharmaceuticals, 184 Front Street East, Unit 801, Toronto, Ontario M5A 4N3, Canada
by Attix Pharmaceuticals
- Reason
- Penicillin Cross Contamination: All lots of all products repackaged and distributed between 01/05/12 and 02/12/15 are being recalled because they were repackaged in a facility with penicillin products without adequate separation which could introduce the potential for cross contamination with penicillin.
- Published
- April 29, 2015
- Distribution
- Nationwide
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FDA Recall
TerminatedTerminated: October 7, 2015Historical recordClass II
Trehalose Dihydrate active pharmaceutical ingredient packaged in varying grams or kg in bags or drums, Attix Pharmaceuticals, 184 Front Street East, Unit 801, Toronto, Ontario M5A 4N3, Canada
by Attix Pharmaceuticals
- Reason
- Penicillin Cross Contamination: All lots of all products repackaged and distributed between 01/05/12 and 02/12/15 are being recalled because they were repackaged in a facility with penicillin products without adequate separation which could introduce the potential for cross contamination with penicillin.
- Published
- April 29, 2015
- Distribution
- Nationwide
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FDA Recall
TerminatedTerminated: October 7, 2015Historical recordClass II
Tramadol HCl active pharmaceutical ingredient packaged in varying grams or kg in bags or drums, Attix Pharmaceuticals, 184 Front Street East, Unit 801, Toronto, Ontario M5A 4N3, Canada
by Attix Pharmaceuticals
- Reason
- Penicillin Cross Contamination: All lots of all products repackaged and distributed between 01/05/12 and 02/12/15 are being recalled because they were repackaged in a facility with penicillin products without adequate separation which could introduce the potential for cross contamination with penicillin.
- Published
- April 29, 2015
- Distribution
- Nationwide
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FDA Recall
TerminatedTerminated: October 7, 2015Historical recordClass II
Tobramycin Base active pharmaceutical ingredient packaged in varying grams or kg in bags or drums, Attix Pharmaceuticals, 184 Front Street East, Unit 801, Toronto, Ontario M5A 4N3, Canada
by Attix Pharmaceuticals
- Reason
- Penicillin Cross Contamination: All lots of all products repackaged and distributed between 01/05/12 and 02/12/15 are being recalled because they were repackaged in a facility with penicillin products without adequate separation which could introduce the potential for cross contamination with penicillin.
- Published
- April 29, 2015
- Distribution
- Nationwide
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FDA Recall
TerminatedTerminated: October 7, 2015Historical recordClass II
Thyroid Porcine active pharmaceutical ingredient packaged in varying grams or kg in bags or drums, Attix Pharmaceuticals, 184 Front Street East, Unit 801, Toronto, Ontario M5A 4N3, Canada
by Attix Pharmaceuticals
- Reason
- Penicillin Cross Contamination: All lots of all products repackaged and distributed between 01/05/12 and 02/12/15 are being recalled because they were repackaged in a facility with penicillin products without adequate separation which could introduce the potential for cross contamination with penicillin.
- Published
- April 29, 2015
- Distribution
- Nationwide
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FDA Recall
TerminatedTerminated: October 7, 2015Historical recordClass II
Thiotepa active pharmaceutical ingredient packaged in varying grams or kg in bags or drums, Attix Pharmaceuticals, 184 Front Street East, Unit 801, Toronto, Ontario M5A 4N3, Canada
by Attix Pharmaceuticals
- Reason
- Penicillin Cross Contamination: All lots of all products repackaged and distributed between 01/05/12 and 02/12/15 are being recalled because they were repackaged in a facility with penicillin products without adequate separation which could introduce the potential for cross contamination with penicillin.
- Published
- April 29, 2015
- Distribution
- Nationwide
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FDA Recall
TerminatedTerminated: October 7, 2015Historical recordClass II
Thimerosal active pharmaceutical ingredient packaged in varying grams or kg in bags or drums, Attix Pharmaceuticals, 184 Front Street East, Unit 801, Toronto, Ontario M5A 4N3, Canada
by Attix Pharmaceuticals
- Reason
- Penicillin Cross Contamination: All lots of all products repackaged and distributed between 01/05/12 and 02/12/15 are being recalled because they were repackaged in a facility with penicillin products without adequate separation which could introduce the potential for cross contamination with penicillin.
- Published
- April 29, 2015
- Distribution
- Nationwide
View recall →
FDA Recall
TerminatedTerminated: October 7, 2015Historical recordClass II
Tetracaine (free base) active pharmaceutical ingredient packaged in varying grams or kg in bags or drums, Attix Pharmaceuticals, 184 Front Street East, Unit 801, Toronto, Ontario M5A 4N3, Canada
by Attix Pharmaceuticals
- Reason
- Penicillin Cross Contamination: All lots of all products repackaged and distributed between 01/05/12 and 02/12/15 are being recalled because they were repackaged in a facility with penicillin products without adequate separation which could introduce the potential for cross contamination with penicillin.
- Published
- April 29, 2015
- Distribution
- Nationwide
View recall →
FDA Recall
TerminatedTerminated: October 7, 2015Historical recordClass II
Terbinafine HCl active pharmaceutical ingredient packaged in varying grams or kg in bags or drums, Attix Pharmaceuticals, 184 Front Street East, Unit 801, Toronto, Ontario M5A 4N3, Canada
by Attix Pharmaceuticals
- Reason
- Penicillin Cross Contamination: All lots of all products repackaged and distributed between 01/05/12 and 02/12/15 are being recalled because they were repackaged in a facility with penicillin products without adequate separation which could introduce the potential for cross contamination with penicillin.
- Published
- April 29, 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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