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FDA RECALLS & COURT ACTIONS: April 22, 1992

Executive Summary

CLASS II -- AK-NEFRIN WITH PHENYLEPHRINE HCI STERILE OPHTHALMIC SOLUTION In 15 ml white squeezable plastic bottles, under Akorn, Ocusa Eye Drops, De La Cruz PDTS; Ojo De Aguila, Grandall Distribution labels. Recall number: D-304-2. Lot number 18908 EXP 2/93. Manufacturer: Walnut Pharmaceuticals, Inc., Los Angeles, California. Recalled by: Walnut Pharmaceuticals, Inc., Abita Springs, Louisiana, by letter Dec. 13, 1991. Firm-initiated recall ongoing. Distribution: Louisiana, California. 15,224 bottles were distributed. Reason: Lack of assurance of sterility. CLASS II -- ARTIFICIAL TEARS STERILE OPHTHALMIC SOLUTION In 15 ml bottles, a clear solution in white opaque plastic vials with dropper fitting, under Phoenix Pharmaceutical, Safety Supply America, Continental Imports, and Maurry Biological labels. Recall number: D-299-2. Lot number 18823 EXP 11/92. Manufacturer: Walnut Pharmaceuticals, Los Angeles, California. Recalled by: Walnut Pharmaceuticals, Inc., Abita Springs, Louisiana, by letter Jan. 10, 1992. Firm-initiated recall ongoing. Distribution: Missouri, California, Arizona. 18,390 bottles were distributed. Reason: Current good manufacturing practice deficiencies. CLASS II -- ARTIFICIAL TEARS WITH PHENYLEPHERENE OPHTHALMIC SOLUTION In 5 ml opaque white plastic squeezable bottles. Recall number: D- 298-2. Lot number 18660. Manufacturer: Walnut Pharmaceuticals, Inc., Los Angeles, California. Recalled by: Walnut Pharmaceuticals, Abita Springs, Louisiana, by letter Dec. 31, 1991. Firm-initiated recall ongoing. Distribution: Colorado. 5,392 bottles were distributed. Reason: Use of unapproved grade of polyvinyl alcohol. CLASS II -- EFFERVESCENT POTASSIUM TABLETS 25 mEq, lime flavored, individually wrapped in foil packets, in boxes of 30, 100 and 250, an Rx preparation of an oral solution of potassium for prevention of potassium depletion. Recall number: D- 316-2. Lot LPS10710-1. Manufacturer: Tower Laboratories Ltd., Centerbrook, Connecticut. Recalled by: Bajamar Chemical Company, Inc., St. Louis, Missouri (responsible firm), by telephone April 9, 1992, followed by letter. Firm-initiated recall ongoing. Distribution: California, New Jersey, Florida, Rhode Island, Michigan, Texas, Virginia, South Dakota. 456 30-tablet boxes, 12 100-tablet boxes, and 1 250-tablet box was distributed. Reason: Labeling does not comply with respect to declaration of Yellow No. 5. CLASS II -- FLUORESCEIN INJECTION USP 25%, a deep reddish brown solution in a 2 ml clear glass ampule. Recall number: D-309-2. Lot number: 19146 EXP 10/92, 19156 EXP 10/92. Manufacturer: Walnut Pharmaceuticals, Inc., Los Angeles, California. Recalled by: Walnut Pharmaceuticals, Inc., Abita Springs, Louisiana, by letter Dec. 30, 1991. Firm-initiated recall ongoing. Distribution: Louisiana, Canada. 17,724 ampules were distributed. Reason: Lack of assurance of sterility. CLASS II -- FLUORESCEIN/PROPARACAINE OPHTHALMIC SOLUTION A clear orange to pale yellow solution in a 5 ml amber glass screw cap bottle, under the Akorn label. Recall number: D-303-2. Lot numbers: 18986 EXP 5/92, 19010 EXP 5/92, 19014 EXP 6/92, 19105 EXP 9/92, 19009 EXP 5/92, 19013 EXP 9/92, 19104 EXP 9/92. Manufacturer: Walnut Pharmaceuticals, Inc., Los Angeles, California. Recalled by: Walnut Pharmaceuticals, Inc., Abita Springs, Louisiana, by letter Dec. 31, 1991. Firm-initiated recall ongoing. Distribution: California, Louisiana. 65,697 bottles were distributed. Reason: Product does not meet pH specifications. CLASS II -- HEPARIN SODIUM INJECTION 1000 USP UNITS/ML A clear colorless solution in clear 30 ml glass vials. Recall number: D-311-2. Lot numbers: 19092 EXP 9/93, 19128 EXP 10/93. Manufacturer: Walnut Pharmaceuticals, Inc., Los Angeles, California. Recalled by: Walnut Pharmaceuticals, Inc., Abita Springs, Louisiana, by letter Dec. 31, 1991. Firm-initiated recall ongoing. Distribution: Louisiana. 14,214 vials of lot 19091 and 13,738 vials of lot 19128. Reason: Use of unapproved manufacturing process. CLASS II -- MAGNESIUM SULFATE INJECTION 10% ampules, a clear colorless solution in 20 ml clear glass ampules. Recall number: D-308-2. Lot number: 19129 EXP 10/92. Manufacturer: Walnut Pharmaceuticals, Inc., Los Angeles, California. Recalled by: Walnut Pharmaceuticals, Inc., Abita Springs, Louisiana, by letter Dec. 31, 1991. Firm-initiated recall ongoing. Distribution: California. 6,100 ampules were distributed. Reason: Lack of assurance of sterility. CLASS II -- METHYLPREDNISOLONE ACETATE SUSPENSION 40 mg/ml and 80 mg/ml injection in a clear glass 5 ml vial, under Americal Pharmaceuticals, URL, In Source, WE Hauck, Stat Pharmaceuticals, Rugby, Maurry Biological, and Merit Pharmaceuticals labels. Recall number: D-306/307-2. Lot numbers: 19191 EXP 06/92, 19316 EXP 12/92, 19354 EXP 11/92, 19385 EXP 12/92, 19388 EXP 01/93, 19436 EXP 01/93. Manufacturer: Walnut Pharmaceuticals, Inc., Los Angeles, California. Recalled by: Walnut Pharmaceuticals, Inc., Abita Springs, Louisiana, by letter Dec. 13, 1991. Firm-initiated recall ongoing. Distribution: Virginia, Georgia, Pennsylvania, California. 45,190 bottles were distributed. Reason: Product does not meet pH specifications. CLASS II -- PRESCRIBING INFORMATION BOOKLET ACCOMPANYING COPPER T MODEL TCU 380U INTRAUTERINE COPPER CONTRACEPTIVE Recall number: D-295-2. Lot numbers: 89569 through 91630. Only portion shipped or potential of being shipped to Arabic speaking countries. Manufacturer: Finishing Enterprises, Inc. (FEI), North Tonawanda, New York. Recalled by: Manufacturer, by letter March 30- 31, 1992. Firm-initiated field correction ongoing. Distribution: Egypt, Morocco, Jordan, Israel. Approximately 3,473,100 units were distributed. Reason: There is an inaccurate translation in the Arabic language portion of the prescribing information booklet. CLASS II -- ROSE BENGAL OPHTHALMIC SOLUTION 1%, in 10 ml opaque white squeezable plastic bottles with a 5 ml fill, indicated for use as a diagnostic reagent under Akorn, Eagle Vision, and Wilson Ophthalmic labels. Recall number: D-300-2. Lot numbers: 18845 EXP 11/91, 18978 EXP 6/92. Manufacturer: Walnut Pharmaceuticals, Inc., Los Angeles, California. Recalled by: Walnut Pharmaceuticals, Inc., Abita Springs, Louisiana, by letter Dec. 13, 1991. Firm-initiated recall ongoing. Distribution: Illinois, Tennessee, Louisiana. 15,736 bottles were distributed. Reason: Product is hypertonic. CLASS II -- SODIUM CHLORIDE OPHTHALMIC SOLUTION 5%, a clear colorless solution in 15 ml opaque white plastic bottles, under Akorn, Medical Ophthalmics labels. Recall number: D- 305-2. Lot number 19124 EXP 10/92. Manufacturer: Walnut Pharmaceuticals, Inc., Los Angeles, California. Recalled by: Walnut Pharmaceuticals, Inc., Abita Springs, Louisiana, by letter Jan. 10, 1992. Firm-initiated recall ongoing. Distribution: Louisiana, Florida. 19,743 bottles were distributed. Reason: Lack of assurance of sterility. CLASS II -- SODIUM HEPARIN INJECTION, USP 40,000 units per ml, a clear colorless solution, in 5 ml clear glass vials. Recall number: D-310-2. Lot number 19110 EXP 8/93. Manufacturer: Walnut Pharmaceuticals, Inc., Los Angeles, California. Recalled by: Walnut Pharmaceuticals, Inc., Abita Springs, Louisiana, by letter Dec. 13, 1991. Firm-initiated recall ongoing. Distribution: California. 1,888 vials were distributed. Reason: Product packaged in unapproved vials. CLASS II -- SODIUM SULFACETAMIDE OPHTHALMIC SOLUTION 10%, 2 ml, a clear colorless solution in a opaque white plastic bottle, under Akorn label. Recall number: D-302-2. Lot numbers: 18980 EXP 5/93, 19011 EXP not provided. Manufacturer: Walnut Pharmaceuticals, Inc., Los Angeles, California. Recalled by: Walnut Pharmaceuticals, Inc., Abita Springs, Louisiana, by letter Jan. 10, 1992. Firm-initiated recall ongoing. Distribution: Louisiana. 24,486 bottles were distributed. Reason: Lack of assurance of sterility. CLASS II -- SULFA-PREDNISOLONE ACETATE OPHTHALMIC SUSPENSION (PREDAMIDE) A white aqueous suspension in opaque white plastic bottles, under Akorn, Occusoft, Medical Ophthalmic and Wilson Ophthalmics labels. Recall number: D-301-2. Lot numbers: 18948 EXP 5/92, 18859 EXP not provided, 19019 EXP 6/92, 19024 EXP 6/92, 19035 EXP 7/92, 19142 EXP 11/92, 19150 EXP 11/92, 19297 EXP 4/93. Manufacturer: Walnut Pharmaceuticals, Inc., Los Angeles, California. Recalled by: Walnut Pharmaceuticals, Inc., Abita Springs, Louisiana, by letter Dec. 13, 1991. Firm-initiated recall ongoing. Distribution: Louisiana, Oklahoma, Florida, Texas. 96,408 bottles were distributed. Reason: Use of unapproved manufacturing process. CLASS III -- DEXAMETHASONE TABLETS 0.75 mg, in 100 and 1000 tablet bottles, under the following labels: Richlyn, Parmed Pharmaceutical, IDE-Interstate, Genetco, URL. Recall number: D-312-2. Lot numbers: 41920 EXP 7/92, 42812 EXP 10/93. Manufacturer: Richlyn Laboratories, Philadelphia, Pennsylvania. Recalled by: Manufacturer, by letter March 25, 1992. Firm-initiated recall ongoing. Distribution: Nationwide. Firm estimates 93,400 tablets remain on market. Reason: Use of unapproved supplier of active ingredient. CLASS III -- E-Z-PAQUE Oral barium sulfate for suspension, in 176 g cups, used as a testing indicator of gastro-intestinal problems. Recall number: D-296-2. Lot number TP0-006. Manufacturer: E-Z-EM, Inc., Westbury, New York. Recalled by: Manufacturer, by phone March 23-24, 1992, followed by letter March 25, 1992. Firm-initiated recall ongoing. Distribution: Great Britain. 234 cases (36 cups per case) were distributed. Reason: Some units were mislabeled as E-Z-HD (another E-Z-EM barium product). CLASS III -- METHYLTESTOSTERONE TABLETS (a, b, c) (a) 10 mg, oral; (b) 10 mg, sublingual; (c) 25 mg, oral, under the following labels: Rugby -- 10 mg -- oral and sublingual (100's only), 25 mg -- oral; Goldline -- 10 mg -- oral and sublingual, 25 mg -- oral (all 100's only); Schein Pharmaceutical -- 10 mg -- oral and sublingual, 25 mg -- oral (all 100's only); United Research Laboratories -- 10 mg -- oral and sublingual, 25 mg -- oral (all 100's only); IDE-Interstate, Inc. -- 10 mg -- oral and sublingual, 25 mg -- oral (all 100's only); Major Pharmaceutical -- 10 mg -- oral and sublingual, 25 mg -- oral (all 100's only); C. O. Truxton, Inc. -- 10 mg -- sublingual (1000's only); Richlyn -- 10 mg -- oral and sublingual, 25 mg -- oral (all in 100's & 1000's). Recall number: D-313/315-2. (a) 43084, 43005, 42865, 42643, 42546, 42307, 42205, 42084, 41906, 41793, 41770; (b) 43085, 43003, 42551, 42463, 42228, 42147, 41907, 41972; (c) 44084, 44048, 43083, 43004, 42956, 42864, 42716, 42642, 42587, 42545, 42498, 42308, 42269, 42204, 42148, 42082, 42033, 41939, 41909, 41794, 41690. Manufacturer: Richlyn Laboratories, Philadelphia, Pennsylvania. Recalled by: Manufacturer, by letter March 25, 1992. Firm-initiated recall ongoing. Distribution: Nationwide. Undetermined quantity. Reason: Use of unapproved supplier of active ingredient. CLASS III -- VARIOUS Rx DRUGS Recall number: D-317-2. All lots. Manufacturer: Various. Recalled by: Morris and Dickson Company, Ltd., Shreveport, Louisiana (distributor), by letter March 5, 1992. Firm-initiated recall ongoing. Distribution: Louisiana, Texas, Arkansas, Oklahoma, Mississippi, Missouri, Kansas. Unknown quantity. Reason: Repackaging of products without accompanying prescribing information inserts.

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