Drug Recall
Terminated
Historical recordClass II
Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate, and Amphetamine Sulfate (Mixed Salts of a Single-Entity Amphetamine Product) Extended-Release Capsules CII 25 mg 20 UD Capsules (5 x 4), Rx, Packaged and Distributed by: American Health Packaging, Columbus, OH ---- Carton NDC 68084-909-32; Blister NDC 68084-909-33
by Amerisource Health Services
- Reason
- Unit Dose Mispackaging; blister cavities may contain more than one tablet /capsule
- Recall initiated
- August 24, 2016
- Reported by FDA
- September 14, 2016
- Distribution
- Product was distributed in the following states: Nationwide
View recall →
Drug Recall
Terminated
Historical recordClass II
Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate, and Amphetamine Sulfate (Mixed Salts of a Single-Entity Amphetamine Product) Extended-Release Capsules, CII 20 mg, 30 UD Capsules (5 x 6), Rx, Packaged and Distributed by: American Health Packaging, Columbus, OH --- Carton NDC 68084-832-25; Blister NDC 68084-832-95
by Amerisource Health Services
- Reason
- Unit Dose Mispackaging; blister cavities may contain more than one tablet /capsule
- Recall initiated
- August 24, 2016
- Reported by FDA
- September 14, 2016
- Distribution
- Product was distributed in the following states: Nationwide
View recall →
Drug Recall
Terminated
Historical recordClass II
Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate, and Amphetamine Sulfate (Mixed Salts of a Single-Entity Amphetamine Product) Extended-Release Capsules CII 15 mg 20 UD Capsules (5 x 4), Rx, Packaged and Distributed by: American Health Packaging, Columbus, OH --- Carton NDC 68084-898-32; Blister NDC 68084-898-33
by Amerisource Health Services
- Reason
- Unit Dose Mispackaging; blister cavities may contain more than one tablet /capsule
- Recall initiated
- August 24, 2016
- Reported by FDA
- September 14, 2016
- Distribution
- Product was distributed in the following states: Nationwide
View recall →
Drug Recall
Terminated
Historical recordClass II
Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate, and Amphetamine Sulfate (Mixed Salts of a Single-Entity Amphetamine Product) Extended-Release Capsules CII 10 mg 30 UD Capsules (5 x 6), Rx, Packaged and Distributed by: American Health Packaging, Columbus, OH --- Carton NDC 68084-815-25; Blister NDC 68084-815-95
by Amerisource Health Services
- Reason
- Unit Dose Mispackaging; blister cavities may contain more than one tablet /capsule
- Recall initiated
- August 24, 2016
- Reported by FDA
- September 14, 2016
- Distribution
- Product was distributed in the following states: Nationwide
View recall →
Drug Recall
Terminated
Historical recordClass II
Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate, and Amphetamine Sulfate Tablets (Mixed Salts of a Single Entity Amphetamine Product) CII 30 mg, 30 UD Tablets (5 x 6), Rx, Packaged and Distributed by: American Health Packaging, Columbus, OH --- Carton NDC 60687-154-25; Blister NDC 60687-154-95
by Amerisource Health Services
- Reason
- Unit Dose Mispackaging; blister cavities may contain more than one tablet /capsule
- Recall initiated
- August 24, 2016
- Reported by FDA
- September 14, 2016
- Distribution
- Product was distributed in the following states: Nationwide
View recall →
Drug Recall
Terminated
Historical recordClass II
Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate, and Amphetamine Sulfate Tablets (Mixed Salts of a Single Entity Amphetamine Product) CII 20 mg, 30 UD Tablets (5 x 6), Rx, Packaged and Distributed by: American Health Packaging, Columbus, OH --- Carton NDC 68084-943-25; Blister NDC 68084-943-95
by Amerisource Health Services
- Reason
- Unit Dose Mispackaging; blister cavities may contain more than one tablet /capsule
- Recall initiated
- August 24, 2016
- Reported by FDA
- September 14, 2016
- Distribution
- Product was distributed in the following states: Nationwide
View recall →
Drug Recall
Terminated
Historical recordClass II
Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate, and Amphetamine Sulfate Tablets (Mixed Salts of a Single Entity Amphetamine Product) CII 15 mg, 30 UD Tablets (5 x 6), Rx, Packaged and Distributed by: American Health Packaging, Columbus, OH ---- Carton NDC 60687-133-25; Blister NDC 60687-133-95
by Amerisource Health Services
- Reason
- Unit Dose Mispackaging; blister cavities may contain more than one tablet /capsule
- Recall initiated
- August 24, 2016
- Reported by FDA
- September 14, 2016
- Distribution
- Product was distributed in the following states: Nationwide
View recall →
Drug Recall
Terminated
Historical recordClass II
Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate, and Amphetamine Sulfate Tablets (Mixed Salts of a Single Entity Amphetamine Product) CII 10 mg, 30 UD Tablets (5 x 6), Rx, Packaged and Distributed by: American Health Packaging, Columbus, OH ---- Carton NDC 68084-936-25; Blister NDC 68084-936-95
by Amerisource Health Services
- Reason
- Unit Dose Mispackaging; blister cavities may contain more than one tablet /capsule
- Recall initiated
- August 24, 2016
- Reported by FDA
- September 14, 2016
- Distribution
- Product was distributed in the following states: Nationwide
View recall →
Drug Recall
Terminated
Historical recordClass II
Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate, and Amphetamine Sulfate Tablets (Mixed Salts of a Single Entity Amphetamine Product) CII 5 mg, 30 UD Tablets (5 x 6), Rx, Packaged and Distributed by: American Health Packaging, Columbus, OH --- Carton NDC 68084-874-25; Blister NDC 68084-874-95
by Amerisource Health Services
- Reason
- Unit Dose Mispackaging; blister cavities may contain more than one tablet /capsule
- Recall initiated
- August 24, 2016
- Reported by FDA
- September 14, 2016
- Distribution
- Product was distributed in the following states: Nationwide
View recall →
Drug Recall
Terminated
Historical recordClass II
Methylprednisolone Acetate/Lidocaine HCl 40/10 mg/mL Injection, 10 mL multidose vial, sterile. Rx only. Compounded by Isomeric Pharmacy Solutions, Salt Lake City, UT 84109,
by Isomeric Pharmacy Solution, LLC
- Reason
- Lack of Processing Controls: Isomeric Pharmacy Solution, LLC announces a voluntary field action for the Methylprednisolone Acetate/Lidocaine HCl 40/10 mg/mL Injection because the sterile injectable products were sterilized too long leading to potential difficulty resuspending particles.
- Recall initiated
- June 29, 2016
- Reported by FDA
- September 14, 2016
- Distribution
- Nationwide and Puerto Rico. No Canadian, other foreign, govt/VA/military consignees.
View recall →
Drug Recall
Terminated
Historical recordClass III
Selegiline HCL Tablets USP 5mg, 60- count bottles, Rx only, Manufactured by: Stason Pharmaceuticals, Inc. Irvine, CA 92618 Distributed by: Libertas Pharma, Inc. Montgomery, AL 36117. NDC 51862-146-06
by Stason Pharmaceuticals, Inc.
- Reason
- Stason Pharmaceuticals is recalling Selegiline HCl tablets, USP 5mg 60 count bottle due to an out of specification result for dissolution of stability samples.
- Recall initiated
- August 23, 2016
- Reported by FDA
- September 14, 2016
- Distribution
- North Carolina
View recall →
Drug Recall
Terminated
Historical recordClass III
CLINIQUE moisture surge tinted moisturizer broad spectrum SPF 15, 1 FL. OZ.LIQ./30 ml bottle within a carton, Clinique Labs., Dist. New York, N.Y., 10022; New York, London W1K 3BQ; Paris, UPC No. 20714-48241-1, Shade 06 (D-G)
by Clinique International
- Reason
- Subpotent Drug: Two of the active sunscreen ingredients, octinoxate and octisalate, are below the specifications for assay.
- Recall initiated
- May 17, 2016
- Reported by FDA
- September 7, 2016
- Distribution
- Nationwide
View recall →
Drug Recall
Terminated
Historical recordClass III
CLINIQUE moisture surge tinted moisturizer broad spectrum SPF 15, 1 FL. OZ.LIQ./30 ml bottle within a carton, Clinique Labs., Dist. New York, N.Y., 10022; New York, London W1K 3BQ; Paris, UPC No. 20714-48240-4, Shade 05 (D-G)
by Clinique International
- Reason
- Subpotent Drug: Two of the active sunscreen ingredients, octinoxate and octisalate, are below the specifications for assay.
- Recall initiated
- May 17, 2016
- Reported by FDA
- September 7, 2016
- Distribution
- Nationwide
View recall →
Drug Recall
Terminated
Historical recordClass III
CLINIQUE moisture surge tinted moisturizer broad spectrum SPF 15, 1 FL. OZ.LIQ./30 ml bottle within a carton, Clinique Labs., Dist. New York, N.Y., 10022; New York, London W1K 3BQ; Paris, UPC No. 20714-47479-9, Shade 04 (M-N)
by Clinique International
- Reason
- Subpotent Drug: Two of the active sunscreen ingredients, octinoxate and octisalate, are below the specifications for assay.
- Recall initiated
- May 17, 2016
- Reported by FDA
- September 7, 2016
- Distribution
- Nationwide
View recall →
Drug Recall
Terminated
Historical recordClass III
CLINIQUE moisture surge tinted moisturizer broad spectrum SPF 15, 1 FL. OZ.LIQ./30 ml bottle within a carton, Clinique Labs., Dist. New York, N.Y., 10022; New York, London W1K 3BQ; Paris, UPC No. 20714-47478-2, Shade 03 (MF-N)
by Clinique International
- Reason
- Subpotent Drug: Two of the active sunscreen ingredients, octinoxate and octisalate, are below the specifications for assay.
- Recall initiated
- May 17, 2016
- Reported by FDA
- September 7, 2016
- Distribution
- Nationwide
View recall →
Drug Recall
Terminated
Historical recordClass III
CLINIQUE moisture surge tinted moisturizer broad spectrum SPF 15, 1 FL. OZ.LIQ./30 ml bottle within a carton, Clinique Labs., Dist. New York, N.Y., 10022; New York, London W1K 3BQ; Paris, UPC No. 20714-47477-5, Shade 02 (VF-N)
by Clinique International
- Reason
- Subpotent Drug: Two of the active sunscreen ingredients, octinoxate and octisalate, are below the specifications for assay.
- Recall initiated
- May 17, 2016
- Reported by FDA
- September 7, 2016
- Distribution
- Nationwide
View recall →
Drug Recall
Terminated
Historical recordClass III
CLINIQUE moisture surge tinted moisturizer broad spectrum SPF 15, 1 FL. OZ.LIQ./30 ml bottle within a carton, Clinique Labs., Dist. New York, N.Y., 10022; New York, London W1K 3BQ; Paris, UPC No. 20714-47476-8, Shade 01 (VF-N)
by Clinique International
- Reason
- Subpotent Drug: Two of the active sunscreen ingredients, octinoxate and octisalate, are below the specifications for assay.
- Recall initiated
- May 17, 2016
- Reported by FDA
- September 7, 2016
- Distribution
- Nationwide
View recall →
Drug Recall
Terminated
Historical recordClass III
Hydrocortisone and acetic acid otic solution, Rx only, 10 mL bottle, Distributed by Actavis Inc. 60 Columbia Road Bldg B. Morristown, NJ 07560 USA , NDC 45963-412-61
by Actavis Inc
- Reason
- Failed Impurities/Degradation Specifications: Out of specification (OOS) results for related compound G were obtained at 12-month (at expiry) stability time-point for room temperature sample(s).
- Recall initiated
- August 2, 2016
- Reported by FDA
- August 31, 2016
- Distribution
- Nationwide and Puerto Rico
View recall →
Drug Recall
Terminated
Historical recordClass III
Acetasol HC (hydrocortisone and acetic acid otic solution USP) , Rx Only, 10 mL bottle, Manufactured by: Actavis Midatlantic LLC 1877 Kawai Road Lincolnton, NJ 28092 USA, NDC 0472-0882-82
by Actavis Inc
- Reason
- Failed Impurities/Degradation Specifications: Out of specification (OOS) results for related compound G were obtained at 12-month (at expiry) stability time-point for room temperature sample(s).
- Recall initiated
- August 2, 2016
- Reported by FDA
- August 31, 2016
- Distribution
- Nationwide and Puerto Rico
View recall →
Drug Recall
Terminated
Historical recordClass II
Amoxicillin for Oral Suspension USP, 400 mg/ 5 mL, 50 mL bottle, Rx only, Manufactured In Canada by: Teva Canada Limited, Toronto, Canada, NDC 0093-4161-76
by Teva North America
- Reason
- Superpotent drug: Out of specification test result for assay during stability testing.
- Recall initiated
- June 24, 2016
- Reported by FDA
- August 31, 2016
- Distribution
- Nationwide
View recall →
This information is republished from FDA's Recall Enterprise System through openFDA. Public Health Trace
does not verify or supplement it, is not affiliated with the FDA, and does not provide medical advice --
always follow the guidance of your pharmacist, physician, or the recalling company for any medication you take.
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