Recall archive
162 recalls · page 7 of 7
Reported Jul 24, 2013
Amoxicillin for Oral Suspension, USP 200 mg/5 mL, a) 75 mL bottle NDC 0093-4160-78 and b) 100 mL bottle NDC…
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.Teva Pharmaceuticals USA, Inc.
Matched: Brand · Product details — Discoloration: This recall is being carried out due to an orange to brown discolored Amoxicillin powder on the inner foil seal of the bottles. This…
FDA (openFDA drug enforcement)
Reported Jul 17, 2013
Lessina(R) (Levonorgestrel and ethinyl estradiol tablets, USP) 0.1 mg/0.02 mg, 28 day regimen, Rx only, Barr…
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.Teva Pharmaceuticals USA, Inc.
Matched: Brand — Failed Impurity/Degradation Specification; an impurity identified as N-Butyl-Benzene Sulfonamide (NBBS) was detected during impurity testing
5 more products in this recall
FDA (openFDA drug enforcement)
Reported Jun 26, 2013
Actiq (oral transmucosal fentanyl citrate) 200 mcg, lozenge on a stick, a)Single Blister (NDC 63459-502-01), b) 30…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Teva Pharmaceuticals USA, Inc.
Matched: Brand — Failed Dissolution Specification; during stability testing
FDA (openFDA drug enforcement)
Reported Jun 19, 2013
Amoxicillin for Oral Suspension, USP 400mg/5mL, NDC 0093-4161-78 (75ml) and 0093-4161-73 (100mL)
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.Teva Pharmaceuticals USA, Inc.
Matched: Brand — Discoloration: This recall is being carried out due to a yellow to brown discolored Amoxicillin powder on the inner foil seal of the bottles.
FDA (openFDA drug enforcement)
Reported Jun 12, 2013
Disulfiram Tablets USP 250 mg, 100 tablet bottle, Rx only, Manufactured for TEVA Pharmaceuticals, USA, Sellersville, PA…
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.Teva Pharmaceuticals USA, Inc.
Matched: Brand · Product · Product details — CGMP Deviation; cotton coil is missing in some packaged bottles
FDA (openFDA drug enforcement)
Reported Jun 5, 2013
Camila 0.35 mg Tablets, 6 cards of 28 pills, Dist. By: Physicians Total Care, Tulsa, OK --- NDC 54868-4814-0, MFG By…
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.Physicians Total Care, Inc.
Matched: Product details — Failed Impurity/Degradation Specification; an impurity identified as N-Butyl-Benzene Sulfonamide (NBBS) was detected during impurity testing
FDA (openFDA drug enforcement)
Reported Jun 5, 2013
Seasonale(R) (Levonorgestrel/Ethinyl Estradiol Tablets), 0.15 mg/0.03 mg, 3 extended-cycle tablet dispensers, 91…
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.Teva Pharmaceuticals USA, Inc.
Matched: Brand · Product details — Failed Impurity/Degradation Specification; an impurity identified as N-Butyl-Benzene Sulfonamide (NBBS) detected during impurity testing
1 more product in this recall
FDA (openFDA drug enforcement)
Reported Apr 24, 2013
Copaxone (glatiramer acetate injection), 20 mg/1 mL, packaged in 30 single use PRE-FILLED syringes and 33 Alcohol Preps…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Teva Pharmaceuticals USA, Inc.
Matched: Brand · Product details — Presence of Foreign Substance: Product is being recalled due to receiving an elevated number of patient complaints related to a visible presence of…
FDA (openFDA drug enforcement)
Reported Apr 17, 2013
Portia (levonorgestrel and ethinyl estradiol) Tablets, USP, 0.15 mg/0.03 mg, 28-count tablets (containing 21 pink…
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.Teva Pharmaceuticals USA, Inc.
Matched: Brand — Failed Tablet/Capsule Specifications: This recall is being carried out due to an out of specification result for appearance.
2 more products in this recall
FDA (openFDA drug enforcement)
Reported Apr 10, 2013
TEV-TROPIN (somatropin (rDNA origin) for injection) 5 mg (15 IU). Prescription Only. Distributed By: TEVA Biologics &…
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.Ferring Pharmaceuticals Inc.
Matched: Brand · Product · Product details — Labeling: Label Mix-up: Units of Lot 201131320087 are packaged in cartons labelled for Needle-Free Head B, but contaiin Needle-Free Head A
FDA (openFDA drug enforcement)
Reported Apr 10, 2013
CLONAZEPAM ORALLY DISINTERGRATING Tablets, USP, 0.5 mg, 60 tablets (10 blister cards of 6 tablets each), TEVA…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Teva Pharmaceuticals USA, Inc.
Matched: Brand · Product · Product details — Failed Content Uniformity Specifications: Recall is being carried out due to an out-of-specification result for content uniformity.
FDA (openFDA drug enforcement)
Reported Apr 3, 2013
PHYSICIANS TOTAL CARE, TETRACYCLINE, 250 mg, 30 CAPSULES, bottle MFG. BY: TEVA PHARMACEUTICALS USA, SELLERSVILLE PA…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Physicians Total Care, Inc.
Matched: Product · Product details — Presence of Foreign Substance(s): There is a potential for foreign particulate matter in the API.
1 more product in this recall
FDA (openFDA drug enforcement)
Reported Mar 20, 2013
Terazosin Hydrochloride Capsules, 2 mg, packaged in a) 100-count bottles (NDC 0093-4337-01); and b) 1000-count bottles…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Teva Pharmaceuticals USA, Inc.
Matched: Brand · Product details — Presence of Foreign Tablets/Capsules: Recall is being conducted due to a foreign capsule found in one bottle.
FDA (openFDA drug enforcement)
Reported Jan 23, 2013
CABERGOLINE Tablets, 0.5 mg, RX only, 8 count bottles, Manufactured For: TEVA PHARMACEUTICALS USA, Sellersville, PA…
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.Teva Pharmaceuticals USA, Inc.
Matched: Brand · Product · Product details — Impurities/Degradation Products: This lot of product will not meet the impurity specification over shelf life
FDA (openFDA drug enforcement)
Reported Aug 15, 2012
Copaxone (glatiramer acetate injection), 20mg/mL, 1 mL , Rx only, Marketed by: Teva Neuroscience - NDC 68546-317-30
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Teva Pharmaceuticals USA, Inc.
Matched: Brand · Product · Product details — Presence of Foreign Substance: Recall is being initiated due to the presence of a foreign particle identified from a customer complaint.
FDA (openFDA drug enforcement)
Reported Jul 11, 2012
Metoprolol Tartrate Tablets USP 50 mg, 1000 count bottle, Rx only, Manufactured in india By: Emcure Pharmaceuticals…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Teva Pharmaceuticals USA, Inc.
Matched: Brand · Product · Product details — Tablet Thickness: Potential for some tablets not conforming to weight specifications (under and over weight)
FDA (openFDA drug enforcement)
Reported Jul 4, 2012
Mefloquine HCL Tablets, 250 mg, 5 tablets per blister pack; 5 Blister packs per carton, Rx only, Teva Pharmaceuticals…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Teva Pharmaceuticals USA, Inc.
Matched: Brand · Product · Product details — Tablet Thickness: Product is being recalled due to the potential of being underweight or overweight.
1 more product in this recall
FDA (openFDA drug enforcement)
Reported Jun 27, 2012
Jolessa (levonorgestrel/ethinyl estradiol tablets, USP) 0.15 mg/0.03 mg, each Dispenser contains 91 tablets, 91 Day…
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.Teva Pharmaceuticals USA, Inc.
Matched: Brand · Product details — Contraceptive Tablets Out of Sequence: This recall has been initiated due to the potential that some regimen packages may not contain placebo tablets.
FDA (openFDA drug enforcement)
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