FDA Recall
TerminatedTerminated: June 21, 2013Historical recordClass III
Endocet (oxycodone and acetaminophen) tablets, USP, 10 mg/650 mg, 100-count tablets per bottle, Rx only, Manufactured for: Endo Pharmaceuticals Inc., Chadds Ford, PA, By: Novartis, Lincoln, NE 68501; NDC 60951-797-70.
by Endo Pharmaceuticals, Inc.
- Reason
- Adulterated Presence of Foreign Tablets: Customer complaint that some Endocet 10 mg/325 mg tablets were found mixed in a bottle with Endocet 10 mg/650 mg tablets.
- Published
- June 20, 2012
- Distribution
- Nationwide
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FDA Recall
TerminatedTerminated: June 28, 2018Historical recordClass II
CONCENTRATED SODIUM CHLORIDE INJECTION, USP, 23.4% a) 30 mL SINGLE DOSE VIAL, (NDC 0517-2930-25), b) 100 mL PHARMACY BULK PACKAGE (NDC 0517-2900-25), Rx Only, AMERICAN REGENT, INC. SHIRLEY, NY 11967.
by Luitpold Pharmaceuticals, Inc.
- Reason
- Presence of Particulate Matter: In the course of inspecting retention samples visual particles were observed.
- Published
- June 20, 2012
- Distribution
- Nationwide
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FDA Recall
TerminatedTerminated: August 21, 2013Historical recordClass II
Octreotide Acetate Injection, 50 mcg/mL (0.05 mg/mL), 1 mL single dose vials, packaged in 10 x 1 mL single dose vials per pack, Rx only, Manufactured for: Bedford Laboratories, Bedford, OH 44146; Manufactured by: Ben Venue Laboratories, Inc., Bedford, OH 44146; NDC 55390-160-10; UPC 3 55390-160-10 1.
by Ben Venue Laboratories Inc
- Reason
- Short Fill: These products are being recalled because there is potential that vials with low fill volume were released into distribution.
- Published
- June 20, 2012
- Distribution
- Nationwide
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FDA Recall
TerminatedTerminated: August 21, 2013Historical recordClass II
Midazolam HCl Injection, 5 mg/mL, 1 mL single use vials, packaged in 10 x 1 mL single use vials per pack, Rx only, Manufactured by: Ben Venue Laboratories, Inc., Bedford, OH 44146; Manufactured for: Bedford Laboratories, Bedford, OH 44146, NDC 55390-138-01; UPC 3 55390-138-01 8.
by Ben Venue Laboratories Inc
- Reason
- Short Fill: These products are being recalled because there is potential that vials with low fill volume were released into distribution.
- Published
- June 20, 2012
- Distribution
- Nationwide
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FDA Recall
TerminatedTerminated: May 23, 2013Historical recordClass II
Daytrana (methylphenidate) transdermal system patch, Delivers 10 mg over 9 hours (1.1 mg/hr), 1 patch per pouch (NDC 54092-552-01), packaged in 30-count patches per box (NDC 54092-552-30), Rx only, Manufactured for Shire US Inc., Wayne, PA 19087; by Noven Pharmaceuticals, Inc., Miami, FL 33186.
by Noven Pharmaceuticals, Inc.
- Reason
- Miscalibrated and/or Defective Delivery System: Out of Specification results for mechanical peel force and/or the z-statistic value which relates to the patient's ability to remove the release liner from the patch adhesive prior to administration.
- Published
- June 20, 2012
- Distribution
- Nationwide
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FDA Recall
TerminatedTerminated: May 23, 2013Historical recordClass II
Daytrana (methylphenidate) transdermal system patch, Delivers 15 mg over 9 hours (1.6 mg/hr), 1 patch per pouch (NDC 54092-553-01), packaged in 30-count patches per box (NDC 54092-553-30), Rx only, Manufactured for Shire US Inc., Wayne, PA 19087; by Noven Pharmaceuticals, Inc., Miami, FL 33186.
by Noven Pharmaceuticals, Inc.
- Reason
- Miscalibrated and/or Defective Delivery System: Out of Specification results for mechanical peel force and/or the z-statistic value which relates to the patient's ability to remove the release liner from the patch adhesive prior to administration.
- Published
- June 20, 2012
- Distribution
- Nationwide
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FDA Recall
TerminatedTerminated: May 23, 2013Historical recordClass II
Daytrana (methylphenidate) transdermal system patch, Delivers 30 mg over 9 hours (3.3 mg/hr), 1 patch per pouch (NDC 54092-555-01), packaged in 30-count patches per box (NDC 54092-555-30), Rx only, Manufactured for Shire US Inc., Wayne, PA 19087 by Noven Pharmaceuticals, Inc., Miami, FL 33186.
by Noven Pharmaceuticals, Inc.
- Reason
- Miscalibrated and/or Defective Delivery System: Out of Specification results for mechanical peel force and/or the z-statistic value which relates to the patient's ability to remove the release liner from the patch adhesive prior to administration.
- Published
- June 20, 2012
- Distribution
- Nationwide
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FDA Recall
TerminatedTerminated: May 23, 2013Historical recordClass II
Daytrana (methylphenidate) transdermal system patch, Delivers 20 mg over 9 hours (2.2 mg/hr), 1 patch per pouch, packaged in 30-count patches per box, Rx only, labeled as a) Manufactured for Shire US Inc., Wayne, PA 19087 by Noven Pharmaceuticals, Inc., Miami, FL 33186; NDC 54092-554-30; b) Manufactured for Noven Therapeutics, LLC, Miami, FL 33186, By Noven Pharmaceuticals, Inc., Miami, FL 33186; NDC 68968-5554-3.
by Noven Pharmaceuticals, Inc.
- Reason
- Miscalibrated and/or Defective Delivery System: Out of Specification results for mechanical peel force and/or the z-statistic value which relates to the patient's ability to remove the release liner from the patch adhesive prior to administration.
- Published
- June 20, 2012
- Distribution
- Nationwide
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FDA Recall
TerminatedTerminated: September 24, 2012Historical recordClass II
Murocel (methylcellulose) Lubricant Opthalmic Solution (USP, 1%), 15 mL bottle, OTC, Manufactured by Bausch & Lomb Incorporated, Tampa, FL 33637, NDC 24208-280-15
by Bausch & Lomb, Inc.
- Reason
- Lack of Assurance of Sterility: Bausch & Lomb, Inc. is recalling 7 Lots of Murocel Methylcellulose Lubricant Opthalmic Solution 1% (15 mL). Product was found to be OOS for Antimicrobial Effectiveness testing (AET) at the 12 month stability time point.
- Published
- June 20, 2012
- Distribution
- Nationwide
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FDA Recall
TerminatedTerminated: August 5, 2013Historical recordClass II
Diazepam Injection, USP, 10 mg Automatic, Autoinjector for Buddy Use, 5 mg/mL, 2 mL autoinjector, 15-count autoinjectors per carton, Rx only, Meridian Medical Technologies, Columbia, MD 21046; A subsidiary of King Pharmaceuticals, Inc.; NSN 6505-01-274-0951, NDC 11704-600-01.
by Meridian Medical Technologies a Pfizer Company
- Reason
- Impurities/Degradation Products: High Out of Specification levels for carbostyril, a known degradation product of diazepam.
- Published
- June 20, 2012
- Distribution
- Nationwide
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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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