FDA Recall
Terminated
Historical recordClass I
Effexor XR (venlafaxine HCl) Extended-Release Capsules, 150 mg, packaged in a) 30-count Unit of Use bottles (NDC 0008-0836-21) UPC 3 0008-0836-21 7; b) 90-count Unit of Use bottles (NDC 0008-0836-22) UPC 3 0008-0836-22 4; Rx only, Distributed by Wyeth Pharmaceuticals Inc., A subsidiary of Pfizer Inc., Philadelphia, PA 19101.
by Pfizer Us Pharmaceutical Group
- Reason
- Presence of Foreign Tablets/Capsules: A Pharmacist reported that a bottle of Effexor XR 150 mg capsules contained a single peach colored capsule printed TKN250 which was identified as a Tikosyn (dofetilide) capsule.
- Published
- May 28, 2014
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass I
PRO ArthMax Dietary Supplement tablets, 750 mg, 120 count bottles, Distributed by Human Science Foundation, Los Angeles, CA
by HUMAN SCIENCE FOUNDATION
- Reason
- Marketed without an Approved NDA/ANDA; FDA analysis found the product to contain Chlorzoxazone, Nefopam, Diclofenac, Ibuprofen, Naproxen, and Indomethacin
- Published
- May 28, 2014
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass I
Acetylcysteine Solution, USP, 10%, 30 mL vial, Rx only, Ben Venue Laboratories, Inc., Bedford, OH, NDC 0054-3025-02
by Ben Venue Laboratories Inc
- Reason
- Presence of Particulate Matter: During a review of retain samples, the firm found a glass particulate in one lot of Acetylcysteine Solution
- Published
- May 28, 2014
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
BUPRENORPHINE HYDROCHLORIDE Sublingual Tablets, 8 mg, 30-count bottles, Rx only, Teva Pharmaceuticals USA, Sellersville, PA 18960, NDC 0093-5379-56, UPC 3 0093-5379-56 2.
by Teva Pharmaceuticals USA
- Reason
- Failed Impurities/Degradation Specifications: High out of specification impurity test results were obtained during stability testing.
- Published
- May 28, 2014
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
BUPRENORPHINE HYDROCHLORIDE Sublingual Tablets, 2 mg, 30-count bottles, Rx only, Teva Pharmaceuticals USA, Sellersville, PA 18960, NDC 0093-5378-56, UPC 3 0093-5378-56 5.
by Teva Pharmaceuticals USA
- Reason
- Failed Impurities/Degradation Specifications: High out of specification impurity test results were obtained during stability testing.
- Published
- May 28, 2014
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Smart Tab First Aid ezRefill System Ibuprofen dispenser boxes (Item Number FAE 7014), 20 count boxes, First Aid Only Inc., Vancouver, WA
by First Aid Only Inc
- Reason
- First Aid Only, Inc is recalling Smart Tab First Aid ezRefill System Ibuprofen boxes and First Aid Cabinets containing these Ibuprofen boxes. Ibuprofen boxes (FAE 7014) were accidentally used to package aspirin packs (10 packs of 2 / 235mg tablets).
- Published
- May 21, 2014
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass I
REUMOFAN PLUS Tablets, 30 Tablet Bottles, OTC. Previene el cancer en los huesos, Nueva presentacion el original.
by Pain Free By Nature
- Reason
- Marketed Without an Approved NDA/ANDA; Product contains undeclared diclofenac and methocarbamol.
- Published
- May 21, 2014
- Distribution
- Nationwide
View recall →
FDA Recall
Completed
Historical recordClass II
Sterile Water for Injection, 5 mL ampoules, packaged in 50-count ampoules per box, Manufactured and Distributed by: Euro Med Laboratories, UPC 4800573016219
by Flawless Beauty LLC
- Reason
- Marketed Without An Approved NDA/ANDA: Product is sold over the counter whose labeling indicates it is to be used for parenteral injection.
- Published
- May 21, 2014
- Distribution
- Nationwide
View recall →
FDA Recall
Completed
Historical recordClass II
Vitamin C (ascorbic acid) Injection, USP, 500 mg per 2 mL, 50 x 2 mL ampoules per box, Manufactured by: TP Drug Laboratories (1969) Co., Ltd., 98 Soi Sukhumvlt 62, Yak 1, Bangchak, Prakanong, Bangkok 10260, Thailand, Reg. No. 1 A 1557/30; UPC 8 853533 000533
by Flawless Beauty LLC
- Reason
- Marketed Without An Approved NDA/ANDA: Parenteral product is sold over the counter whose labeling indicates it is to be used for the treatment of disease.
- Published
- May 21, 2014
- Distribution
- Nationwide
View recall →
FDA Recall
Completed
Historical recordClass II
Relumins Advanced Glutathione (lyophilized glutathione/vitamin C) injectable solution, 1500 mg/500 mg, packaged in 8-count vials, 8-count 5 mL vitamin C (ascorbic acid) solution diluent ampoules, and 30-count Advanced Glutathione Boosters capsules per box, Relumins Labs, 183 Locust Avenue, West Long Branch, NJ 07764, UPC 700175760302
by Flawless Beauty LLC
- Reason
- Marketed Without An Approved NDA/ANDA: Product is sold over the counter whose labeling indicates it is to be used parenterally for drug claims.
- Published
- May 21, 2014
- Distribution
- Nationwide
View recall →
FDA Recall
Completed
Historical recordClass II
Saluta (reduced glutathione) Powder for Injection, 600 mg/vial, packaged in 10 vials per box, Exclusively Distributed by: QAF Pharmaceuticals Inc. Philippines, Unit Unit 202 ECG Building, Multinational Avenue, Multinational Village, Parahaque City, Metro Manila Philippines; Manufactured by: Shandong Luye Pharmaceutical Co. Ltd, Yantai Shandong, PRC la Luye Pharma Subsidiary, UPC 6920425209014
by Flawless Beauty LLC
- Reason
- Marketed Without An Approved NDA/ANDA: Parenteral product is labeled for use as an antidote.
- Published
- May 21, 2014
- Distribution
- Nationwide
View recall →
FDA Recall
Completed
Historical recordClass II
Tatiomax (reduced glutathione/hydrolyzed collagen) powder for injection vials, 1200 mg/200 mg, 10-count vials per box, Manufactured by: Sujie Pharmaceutical Ltd., Tokyo, Japan, UPC 4973430081576
by Flawless Beauty LLC
- Reason
- Marketed Without An Approved NDA/ANDA: Product is sold over the counter whose labeling includes drug claims to act as an antidote.
- Published
- May 21, 2014
- Distribution
- Nationwide
View recall →
FDA Recall
Completed
Historical recordClass II
Laroscorbine Platinium (vitamin C/collagen) injectable I.V. solution, 1 gm/0.35 gm, 5 mL ampoules, packaged in 10-count ampoules per box, Laboratories Roche Nicholas S.A., F-74240 Gaillard, - Tel.: 04 50 87 70 70, Fabricant : Produits Roche, 52, Bld du Parc, 92521 Neulilly -sur-Seine Cedex, barcode *3421357*
by Flawless Beauty LLC
- Reason
- Marketed Without An Approved NDA/ANDA: Product is sold over the counter whose labeling includes drug claims to act as an antidote.
- Published
- May 21, 2014
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
INDOMETHACIN Capsules USP, 50 mg, a) 100 count bottle, (NDC 0093-4030-01), b) 500 count bottle, (NDC 0093-4030-05), Manufactured In INDIA By: EMCURE PHARMACEUTICALS LTD harmaceuticals Ltd., Hinjwadi, Pune, India, Manufactured For: TEVA PHARMACEUTICALS USA, Sellersville, PA 18960
by Teva Pharmaceuticals USA
- Reason
- CGMP Deviations; laboratory testing was not followed in accordance with GMP requirements.
- Published
- May 21, 2014
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
INDOMETHACIN Capsules USP, 25 mg 100 count bottle, Rx only , Manufactured In INDIA By: EMCURE PHARMACEUTICALS LTD harmaceuticals Ltd., Hinjwadi, Pune, India, Manufactured For: TEVA PHARMACEUTICALS USA, Sellersville, PA 18960, NDC 0093-4029-01
by Teva Pharmaceuticals USA
- Reason
- CGMP Deviations; laboratory testing was not followed in accordance with GMP requirements
- Published
- May 21, 2014
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
GLYBURIDE and METFORMIN HYDROCHLORIDE Tablets USP, 5mg/500mg, 500 count bottle, Manufactured In INDIA By: EMCURE PHARMACEUTICALS LTD harmaceuticals Ltd., Hinjwadi, Pune, India, Manufactured For: TEVA PHARMACEUTICALS USA, Sellersville, PA 18960, NDC: 0093-5712-05
by Teva Pharmaceuticals USA
- Reason
- CGMP Deviations; laboratory testing was not followed in accordance with GMP requirements
- Published
- May 21, 2014
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
METHYLDOPA Tablets USP, 500 mg, 100 count bottle, Rx only, Manufactured In INDIA By: EMCURE PHARMACEUTICALS LTD harmaceuticals Ltd., Hinjwadi, Pune, India, Manufactured For: TEVA PHARMACEUTICALS USA, Sellersville, PA 18960, NDC 0093-2932-01
by Teva Pharmaceuticals USA
- Reason
- CGMP Deviations; laboratory testing was not followed in accordance with GMP requirements
- Published
- May 21, 2014
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass III
Mercaptopurine Tablets USP, 50 mg, 25 count bottle, Rx only, Roxanne Laboratories, Inc., Columbus, Ohio, 43216, NDC 0054-4581-11
by Boehringer Ingelheim Roxane Inc
- Reason
- Labeling: Incorrect or Missing Lot and/or Exp Date: This recall is being conducted because the product was given 36 month expiration dates instead of the filed 24 months.
- Published
- May 14, 2014
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass III
Azathioprine Tablets USP, 50 mg, 100 count bottle, Rx only, Roxanne Laboratories, Inc., Columbus, Ohio, 43216, NDC 0054-4084-25
by Boehringer Ingelheim Roxane Inc
- Reason
- Labeling: Incorrect or Missing Lot and/or Exp Date: This recall is being conducted because the product was given 36 month expiration dates instead of the filed 24 months.
- Published
- May 14, 2014
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass III
Liptruzet (ezetimibe and atorvastin) tablets,10 mg/80 mg, a) 30 count blister (NDC 66582-323-30), b) 90 count blister (NDC 66582-323-54), Rx only, Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc, Whitehouse Station, NJ 08889
by Merck & Co Inc
- Reason
- Defective Container; some of the outer laminate foil pouches allowed in air and moisture, which could potentially decrease the effectiveness or change the characteristics of the product.
- Published
- May 14, 2014
- 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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