FDA Recall
TerminatedTerminated: February 21, 2017Historical recordClass III
Fluorescein Sodium Ophthalmic Strips USP, 0.6 mg per strip, labeled as 1) Fluorescein GloStrips, individually wrapped strip (NDC 51801-003-01), barcode (01)00351801003012, packaged in a) 100-count strips per carton (NDC 51801-003-40, UPC 3 51801 00340 1); and b) 300-count strips per carton (NDC 51801-003-50, UPC 3 51801 00350 0), Nomax, Inc., St. Louis, MO 63123 USA; and 2) FUL-GLO, individually wrapped strip (NDC 1748-403-03), barcode (01)00317478403036, packaged in 300-count strips per carton (NDC 17478-403-030, UPC 3 17478-403-03 6), Manufactured for: Akorn, Inc., Lake Forest, IL 60045.
by Nomax Inc
- Reason
- Failed Content Uniformity Specifications: The product may not meet finished product release specifications, including the uniformity of dosage due to a packaging degradation related to the adhesive component of the paper pouch that can impact the level of fluorescein present in the strips.
- Published
- April 29, 2015
- Distribution
- Nationwide
View recall →
FDA Recall
TerminatedTerminated: November 4, 2016Historical recordClass II
0.9% Sodium Chloride Injection, USP, 100 mL ADD-Vantage Unit, Rx only, Manufactured by Hospira Inc., Lake Forest, IL, 60045, NDC: 0409-7101-67
by Hospira Inc.
- Reason
- Lack of Sterility Assurance: The product has the potential to leak at the administrative port.
- Published
- April 29, 2015
- Distribution
- Nationwide
View recall →
FDA Recall
TerminatedTerminated: March 3, 2017Historical recordClass II
Well at Walgreens Regular Strength Antacid Liquid, Mint Flavor 12 FL OZ (355 mL) bottle
by Tarmac Products, Inc.
- Reason
- Products failed the Antimicrobial Effectiveness Test.
- Published
- April 29, 2015
- Distribution
- Nationwide
View recall →
FDA Recall
TerminatedTerminated: March 3, 2017Historical recordClass II
Well at Walgreens Maximum Strength Comfort Gel 12 FL OZ (355 mL) bottle,
by Tarmac Products, Inc.
- Reason
- Products failed the Antimicrobial Effectiveness Test
- Published
- April 29, 2015
- Distribution
- Nationwide
View recall →
FDA Recall
TerminatedTerminated: October 7, 2015Historical recordClass II
Zonisamide 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
Zoledronic Acid 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
Zinc Pyrithione 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
Vidarbine Monophosphate 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
Venlafaxine 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 →
FDA Recall
TerminatedTerminated: October 7, 2015Historical recordClass II
Vecuronium Bromide 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
Valacyclovir 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 →
FDA Recall
TerminatedTerminated: October 7, 2015Historical recordClass II
Ursodiol 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
Uridine-5'Triphosphate Trisodium Salt 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
Trimeprazine Tartrate 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
Trifluridine 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
Tranilast 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
Tranexamic Acid 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
Topiramate 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
Tolvaptan 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
Tizanidine 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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