Drug and pharmaceutical recalls
17747 federal recalls on file. Federal recalls for prescription drugs, OTC medications, supplements, and pharmaceuticals. Sourced from the FDA and translated into plain English.
- 2012-08-15FDA-DrugOklahoma Respiratory Care IncClass IIOXYGEN, COMPRESSED USP MEDICAL GAS in the following containers: E Cylinder 680L, D Cylinder 425L, and M6 Cylinder 165L, Rx only, Oklahoma Respiratory Care, Norman, OK
CGMP Deviations; no identity or purity testing on incoming oxygen gas, and lack of documentation
- 2012-08-15FDA-DrugHospira Inc.Class IHYDROmorphone HCl Injection, USP, 1 mg/mL, 1 mL fill in a 2.5 mL Carpuject prefilled cartridge unit, packaged in 10-count Carpujects per carton, Rx only, Hospira, Inc., Lake Forest, IL 60045, NDC 0409-1283-31, Barcode (01) 1 030409 128331 9 (carton), (01) 0 030409 128331 2 (cartridge unit).
Superpotent (Single Ingredient) Drug: Some of the prefilled cartridge units have been found to be overfilled and contain more than the 1 mL labeled fill volume.
- 2012-08-15FDA-DrugApotex Corp.Class IIMeloxicam Tablets, USP, 15 mg, Rx Only, 100 Tablets per Bottle, Manufactured by: Strides Acrolab Ltd., Bangalore-560 076, India, Manufactured for: Apotex Corp., Weston, FL 33326, NDC 60505-3579-1.
Tablet Thickness: Recall was initiated due to the presence of one slightly oversized tablet in a bottle of the identified lot.
- 2012-08-15FDA-DrugTeva Pharmaceuticals USA, Inc.Class IICopaxone (glatiramer acetate injection), 20mg/mL, 1 mL , Rx only, Marketed by: Teva Neuroscience - NDC 68546-317-30
Presence of Foreign Substance: Recall is being initiated due to the presence of a foreign particle identified from a customer complaint.
- 2012-08-08FDA-DrugAxcentria Pharmaceuticals LLCClass IIIMajor brand Infants' Mapap, Acetaminophen Concentrated Drops, 1 FL. OZ. (30 mL.) 80 mg. per 0.8 mL, Cherry Flavor, Distributed by MAJOR PHARMACEUTICALS, Livonia, MI --- NDC 0904-5255-30,
Labeling; labeled with incorrect EXP Date; Incorrect expiration date printed on the outer packaging. Package incorrectly states 5/2014 should correctly state 4/2014
- 2012-08-08FDA-DrugVistaPharm, Inc.Class IIXactdose Phenytoin Oral Suspension, USP 125 mg/5mL, supplied in 5 mL unit dose cups, VISTAPHARM, Largo, FL NDC 66689-036-50
Defective container; lidding deformity allows the contained product to transpire causing potential viscosity and assay failures. The viscosity and assay failures were due to the loss of moisture. The loss of moisture caused the viscosity to increase and assay to increase relative to the sample volume.
- 2012-08-08FDA-DrugApotex Inc.Class IIDorzolamide HCI/Timolol Maleate Ophthalmic Solution 22.3mg/6.8mg per mL, 10mL bottle, For Topical Application in the Eye, Sterile Ophthalmic Solution, Rx Only, Mfg by: Apotex Inc., Toronto, Ontario, Canada M9L 1T9
Presence of Particulate Matter: Lots identified in this recall notification may contain small particulates.
- 2012-08-08FDA-DrugWest-ward Pharmaceutical Corp.Class IIFosphenytoin Sodium Injection, USP, 500 mg PE per 10 mL (50 mg PE per mL), 10 mL Single Dose Vial, packaged in 10-count x 10 mL Single Dose Vials per carton, Rx only, Mfd. By: Hikma Farmaceutica (Portugal), S.A.; Dist. By: West-Ward Pharmaceutical Corp., Eatontown, NJ 07724 USA under the labels a) NOVAPLUS (NDC 0143-9703-10), b) West-Ward (NDC 0143-9782-10).
Presence of Particulate Matter: This product is being recalled due to the discovery of particles in the stability samples and retain samples.
- 2012-08-08FDA-DrugWest-ward Pharmaceutical Corp.Class IIFosphenytoin Sodium Injection, USP, 100 mg PE per 2 mL (50 mg PE per mL), 2 mL Single Dose Vial, packaged in 25-count x 2 mL Single Dose Vials per carton, Rx only, Mfd. By: Hikma Farmaceutica (Portugal), S.A.; Dist. By: West-Ward Pharmaceutical Corp., Eatontown, NJ 07724 USA under the labels a) NOVAPLUS (NDC 0143-9704-25), b) West-Ward (NDC 0143-9788-25).
Presence of Particulate Matter: This product is being recalled due to the discovery of particles in the stability samples and retain samples.
- 2012-08-08FDA-DrugWatson Laboratories IncClass IIICaziant (desogestrel and ethinyl estradiol) Tablets, USP, (Triphasic Regimen), 0.1 mg/0.025 mg, 0.125 mg/0.025 mg, 0.15 mg/0.025 mg, 28-count tablets per dispenser (NDC 52544-959-28), packaged in 3-count Tablet Dispensers per carton (NDC 52544-959-31), Rx only Manufactured by: Watson Laboratories, Inc., Corona, CA 92880; Distributed by: Watson Pharma, Inc., Corona, CA 92880.
Impurities/Degradation Products: High Out-of-specification results were obtained for both known and unknown impurities.
- 2012-08-08FDA-DrugDr. Reddy's Laboratories, Inc.Class IIDr. Reddy's Ciprofloxacin Tablets, USP 500 mg*, 500 Tablets, Rx only, Mfd. By: Dr. Reddy's Laboratories Limited, Bachepalli - 502 325 INDIA, NDC 55111-127-05
Adulterated Presence of Foreign Tablets: Dr. Reddy's Laboratories has received complaints of mislabeled bottles of Amlodipine Besylate and Benazepril Hydrochloride Capsules and Ciprofloxacin Tablets
- 2012-08-08FDA-DrugDr. Reddy's Laboratories, Inc.Class IIDr. Reddy's Amlodipine Besylate and Benazepril Hydrochloride 5 mg*/20 mg, 500 Capsules, Rx only, Mfd. By: Dr. Reddy's Laboratories Limited, Bachepalli - 502 325 INDIA, NDC 55111-340-05
Adulterated Presence of Foreign Tablets: Dr. Reddy's Laboratories has received complaints of mislabeled bottles of Amlodipine Besylate and Benazepril Hydrochloride Capsules and Ciprofloxacin Tablets.
- 2012-08-08FDA-DrugBayer HealthCare Pharmaceuticals Inc.Class IIEstradiol Hemihydrate M20 EP/USP Powder, packaged in a) 1.5 kg and b) 2.5 kg fiber drums, Rx only, Art. No. 165811, Bayer Pharma AG, D-13342 Berlin.
Cross Contamination w/Other Products: This active pharmaceutical ingredient is being recalled due to cross contamination with another product.
- 2012-08-08FDA-DrugCadence PharmaceuticalsClass IIOFIRMEV (acetaminophen) injection, 1000 mg/100 mL (10 mg/mL), 24-count Single Use 100 mL Vials per carton, Rx only, Manufactured for: Cadence Pharmaceuticals, Inc., San Diego, CA 92130, NDC 43825-102-01, UPC 3 43825 10201 7.
Presence of Particulate Matter: The firm initiated the recall due to visible presence of particulate matter.
- 2012-08-08FDA-DrugMallinckrodt Inc.Class IIHydrocodone Bitartrate and Acetaminophen Oral Solution, 7.5 mg/500 mg per 15 mL, 16 fl oz (473 mL) bottle, Rx only, Mallinckrodt Inc., Hazelwood, MO 63042 USA, NDC 0406-0375-16, UPC 3 0406-0375-16 1.
CGMP Deviations: This product is being recalled because expired flavoring was used in the manufacturing of these lots.
- 2012-08-08FDA-DrugMallinckrodt Inc.Class IIIHydrocodone Bitartrate and Acetaminophen Oral Solution, 7.5 mg/500 mg per 15 mL, 16 fl oz (473 mL) bottle, Rx only, Mallinckrodt Inc., Hazelwood, MO 63042 USA, NDC 0406-0375-16, UPC 3 0406-0375-16 1.
Subpotent (Multiple Ingredient) Drug: Low out of specification assay results for the hydrocodone bitartrate ingredient was found.
- 2012-08-08FDA-DrugEagle Pharmaceuticals Inc.Class IArgatroban Injection 50 mg per 50ml (1 mg per ml) For Intravenous Infusion Only, a) Single Use Vial (NDC 42367-203-07), b) 10 Single Use Vials(NDC 42367-203-84), Rx Only, Manufactured by: Cipla LTD, India, Manufactured for: Eagle Pharmaceuticals, Inc. Woodcliff Lake, NJ 07677 USA, Marketed by: The Medicines Company, Parsippany, NJ 07054 USA
A complaint was received from a hospital pharmacy on 11/10/11 for crystalline particulates in a single vial from Lot V10194. Additional small visible particles consisting of fibers were identified.
- 2012-08-08FDA-DrugZydus Pharmaceuticals USA IncClass IIMetformin Hydrochloride Tablets, USP, 1000 mg, Rx only, 1000 count tablets per Bottle, Manufactured by: Cadila Healthcare LTD. Ahmedabad, India, Distributed by: Zydus Pharmaceuticals USA Inc. Pennington, NJ 08534, NDC 68382-030-10.
Presence of Foreign Substance(s): A product complaint was received from a pharmacist who discovered that several tablets displayed brown specks. The same complainant also reported that metal shaving like material was observed on the surface of one tablet.
- 2012-08-01FDA-DrugStat Rx USAClass IIITizanidine (Generic for: Zanaflex), 4 mg, 90 Tablets per Bottle, Rx only, , Mfg By: Dr Reddys Labs Ltd., Bachepally, IN 500 - 090, Packaged and distributed by STAT Rx USA, Gainesville, GA, NDC 16590-221-90.
Labeling: Label Mix-Up; Some bottles of Tizanidine 4mg Tablets, had the incorrect manufacturer (Actavis) printed on the label.
- 2012-08-01FDA-DrugFougera Pharmaceuticals, Inc.Class IIIErythromycin Topical Solution USP, 2%, 60 mL bottle with applicator, Rx only. E. FOUGERA & CO., A division of Fougera Pharmaceuticals, Inc., Melville, New York 11747, NDC 0168-0215-60, UPC 3 0168-0215-60 0.
Chemical Contamination: This product is being recalled because trace amounts of a plasticizer (Di-Octyl Phthalate) may be present in the product.
- 2012-08-01FDA-DrugGrandpa Brands CoClass IIDent's Extra Strength Toothache Gum, (benzocaine 20%), Net Wt. .035 Oz.. (1 g) box, C.S. Dent & Co., Erlanger, KY
Superpotent; benzocaine
- 2012-07-25FDA-DrugBayer Healthcare, LLCClass IIIMidol Complete, Acetaminophen, Caffeine, Pyrilamine Maleate, Caplets, OTC, a) 16 ct. blister (NDC 0280-8005-16), b)24 ct. blister, Distributed by Bayer Health Care, Morristown, NJ 07962 (NDC 0280-8005-25)
Labeling: Label Mix-up: This recall was initiated after identifying that the label statement on the blister strip regarding the maximum number of capsules/caplets that should be taken within a 24-hour period, does not match the statement on the carton.
- 2012-07-25FDA-DrugBayer Healthcare, LLCClass IIIMidol Complete, Acetaminophen, Caffeine, Pyrilamine Maleate, Gelcaps 24 ct. blister, OTC, Distributed by Bayer Health Care, Morristown, NJ 07962 NDC 0280-8015-24
Labeling: Label Mix-up: This recall was initiated after identifying that the label statement on the blister strip regarding the maximum number of capsules/caplets that should be taken within a 24-hour period, does not match the statement on the carton.
- 2012-07-25FDA-DrugPack PharmaceuticalsClass IIICiprofloxacin Tablets, USP, 500 mg, Rx Only, 100 Tablets per Bottle, Manufactured in India by: Unique Pharmaceutical Laboratories (A Division of J.B. Chemicals & Pharmaceuticals Ltd.), Mumbai - 400 030, Distributed by: PACK Pharmaceuticals, LLC, Buffalo Grove, IL 60089, NDC 16571-412-10.
Labeling Illegible: Missing Label; The voluntary recall of the aforementioned batch of product is being initiated due to two bottles missing container labels.
- 2012-07-25FDA-DrugLuitpold Pharmaceuticals, Inc.Class IIEpinephrine Injection, USP, 1:1000 (1 mg/mL), 25 x 1 mL Ampules, For SC and IM Use, For IV and IC Use after Dilution, Rx Only, American Regent, Inc., Shirely, NY 11967 --NDC 0517-1071-25
Presence of Particulate Matter
- 2012-07-25FDA-DrugJHP Pharmaceuticals, LLCClass IIIPitocin (Oxytocin Injection, USP) Synthetic 10 units per mL 10 mL, Rx only, Manufactured and Distributed by: JHP Pharmaceuticals, LLC Rochester, MI 48307 NDC 42023-116-02
Labeling: Label Mix-up: Pitocin storage conditions should be labeled, "Store between 20¿ to 25¿C (68¿ to 77¿F)". Pitocin lot 225867 and part of Pitocin lot 231423 were labeled, "Store between 20¿ to 25¿C (28¿ to 77¿F)".
- 2012-07-25FDA-DrugHospira Inc.Class IMorphine Sulfate Injection, USP, 4mg/mL, 1 mL fill in 2.5 mL Carpuject Cartridge Unit with Luer Lock, packaged 10 Carpujects/carton, CII, Rx only, Hospira, Inc., Lake Forest, IL ---- NDC 0409-1258-30
Superpotent; Cartridges labeled to contain 1 mL found to contain 2.2 mL
- 2012-07-25FDA-DrugMeda Pharmaceuticals Inc.Class IIPrefera OB One Gel Capsules, 30 softgels, Rx Only, Manufactured by: IVC industries, Inc. Irving ton, NJ 07111, For: Alaven Pharmaceutical LLC Marietta, GA 30062, NDC 68220-086-30
Labeling: Presence of Undeclared Color Additive; The product is being recalled because several inactive ingredients were not included in the labeling for this product: Undeclared D&C Red #33, FD&C Blue #1, Titanium Dioxide Suspension, Purified Water USP.
- 2012-07-25FDA-DrugVintage Pharmaceuticals LLC DBA Qualitest PharmaceuticalsClass IIIHYDROXYZINE HYDROCHLORIDE ORAL SOLUTION, USP, 10 mg/5 mL, 1 PINT (473 mL) bottle, Rx only, Mfg. for: QUALITEST PHARMACEUTICALS, HUNTSVILLE, AL 35811, NDC 0603-1310-58, UPC 3 0603-1310-58 4.
Impurities/Degradation Products: High Out of Specification results for a known impurity resulted at the 12-month room temperature time point.
- 2012-07-18FDA-DrugVistaPharm, Inc.Class IIHydrocodone Bitartrate & Acetaminophen Oral Solution 7.5 mg/325 mg per 15 mL, a) 15 mL Unit Dose Cups (50 unit dose cups per case), b) 473 mL Bottles, C III, Rx Only, Warning May be habit forming, Manufactured by VistaPharm, Largo, FL 33771, NDC a) 66689-023-50, b) NDC 66689-023-16.
Impurities/Degradation Products: exceeded specification at 3 month stability testing
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