FDA Drug Recalls in 2017

1,073 recalls found

May 2017

FDA

Estriol, For Prescription Compounding, packaged in a) 1 G bottle (NDC: 51552-1392-1), b) 5 G bottle (NDC: 51552-1392-2), c) 25 G bottle (NDC: 51552-1392-3), d) 100 G bottle (NDC: 51552-1392-5), RX only, Distributed by Fagron, Inc. 2400 Pilot Knob Rd, St. Paul, MN 55120 Tel. 1-(800) 423-6967 Also packaged as: Estriol USP Micronized, For prescription compounding, packaged in a 100 G bottle (NDC 52372-9292-01), Rx only, Distributed by FREEDOM, 801 W. New Orleans St. Broken Arrow, OK 74011

cGMP Deviations: lack of quality assurance at the API manufacturer.
FDA

Fentanyl Citrate and Bupivacaine HCl all strengths, all dosage forms and all packaging, Rx Only, Avella of Houston, Houston, TX 77054

Labeling: Not Elsewhere Classified: Products may contain synthetic latex and/or natural latex.
FDA

Benzonatate capsules, 200 mg, 100-count bottle, Rx only, Manufactured by: Strides Shasun Limited Bangaluru -560076 India, Distributed by Strides Pharma Inc East Brunswick, NJ 08816, NDC 64380-713-06

Failed Stability Specifications: Out of Specification results obtained for preservative Methylparaben content.
FDA

Ephedrine Sulfate all strengths, all dosage forms and all packaging, Rx Only, Avella of Houston, Houston, TX 77054

Labeling: Not Elsewhere Classified: Products may contain synthetic latex and/or natural latex.
FDA

Penicillin G Potassium all strengths, all dosage forms and all packaging, Rx Only, Avella of Houston, Houston, TX 77054

Labeling: Not Elsewhere Classified: Products may contain synthetic latex and/or natural latex.
FDA

Sodium Citrate all strengths, all dosage forms and all packaging, Rx Only, Avella of Houston, Houston, TX 77054

Labeling: Not Elsewhere Classified: Products may contain synthetic latex and/or natural latex.
FDA

Tarina Fe 1/20 (Norethindrone Acetate and Ethinyl Estradiol Tablets, USP and Ferrous Fumarate Tablets), 1 blister pack containing 28 tablets (NDC 50102-128-01), packaged in 3 pouches, each pouch contains one blister pack of 28 tablets (NDC 50102-128-03), Rx only, Manufactured for: Afaxys, Inc., Charleston, SC 29403, USA, Product of India.

Chemical Contamination: out of specification results for impurities were found to be the result of contamination of product from vapors associated with paint thinner used in repair of the manufacturing room.
FDA

Alprazolam Extended-release Tablets, USP, 1 mg, 60-count bottle, Rx Only, Manufactured and Distributed by: Mylan Pharmaceuticals Inc., Morgantown, WV 26505 U.S.A., NDC 0378-5022-91

Failed Dissolution Specifications
FDA

Midazolam HCl all strengths, all dosage forms and all packaging, Rx Only, Avella of Houston, Houston, TX 77054

Labeling: Not Elsewhere Classified: Products may contain synthetic latex and/or natural latex.
FDA

Optic Splash (naphazoline hydrochloride) Eye Drops, packaged in 0.5 FL OZ (15mL) bottles, Manufactured by SATO Pharmaceuticals CO., LTD. 1-5-27 Motoakasaka Minato-Ku Tokyo, Japan, NDC 49873-501-01.

Lack of Assurance of Sterility: Firm failed to establish an adequate system for monitoring environmental conditions in aseptic processing areas.
FDA

Standard Starter TPN all strengths, all dosage forms and all packaging, Rx Only, Avella of Houston, Houston, TX 77054

Labeling: Not Elsewhere Classified: Products may contain synthetic latex and/or natural latex.
FDA

Amiodarone all strengths, all dosage forms and all packaging, Rx Only, Avella of Houston, Houston, TX 77054

Labeling: Not Elsewhere Classified: Products may contain synthetic latex and/or natural latex.
FDA

Adenosine all strengths, all dosage forms and all packaging, Rx Only, Avella of Houston, Houston, TX 77054

Labeling: Not Elsewhere Classified: Products may contain synthetic latex and/or natural latex.
FDA

Betamethasone Sodium Phosphate & Betamethasone Acetate all strengths, all dosage forms and all packaging, Rx Only, Avella of Houston, Houston, TX 77054

Labeling: Not Elsewhere Classified: Products may contain synthetic latex and/or natural latex.
FDA

Diltiazem HCl all strengths, all dosage forms and all packaging, Rx Only, Avella of Houston, Houston, TX 77054

Labeling: Not Elsewhere Classified: Products may contain synthetic latex and/or natural latex.
FDA

TPN Neonatal all strengths, all dosage forms and all packaging, Rx Only, Avella of Houston, Houston, TX 77054

Labeling: Not Elsewhere Classified: Products may contain synthetic latex and/or natural latex.
FDA

Famotidine HCl all strengths, all dosage forms and all packaging, Rx Only, Avella of Houston, Houston, TX 77054

Labeling: Not Elsewhere Classified: Products may contain synthetic latex and/or natural latex.
FDA

Lidocaine all strengths, all dosage forms and all packaging, Rx Only, Avella of Houston, Houston, TX 77054

Labeling: Not Elsewhere Classified: Products may contain synthetic latex and/or natural latex.
FDA

Bupivacaine HCl in 0.9% Sodium Chloride all strengths, all dosage forms and all packaging, Rx Only, Avella of Houston, Houston, TX 77054

Labeling: Not Elsewhere Classified: Products may contain synthetic latex and/or natural latex.
FDA

0.9% Sodium Chloride Slip Tip all strengths, all dosage forms and all packaging, Rx Only, Avella of Houston, Houston, TX 77054

Labeling: Not Elsewhere Classified: Products may contain synthetic latex and/or natural latex.
FDA

Refresh Tears (Carboxymethylcellulose Sodium Solution) 0.5%, Lubricant Eye Drops, Sterile packaged as 1) two 15 mL bottles, USPC Code 784190442214, 2) 4x15 mL and one 5 mL bonus bottles, USPC Code 069886941746, Distributed by Cell Distributors, Union, NJ

Labeling: Not elsewhere classified; product labeling lacks a NDC number, net weight information and does not contain the Drug Facts Panel.
FDA

ADD HEPARIN PF 50 Units ONLY TO TPN all strengths, all dosage forms and all packaging, Rx Only, Avella of Houston, Houston, TX 77054

Labeling: Not Elsewhere Classified: Products may contain synthetic latex and/or natural latex.
FDA

Magnesium Sulfate all strengths, all dosage forms and all packaging, Rx Only, Avella of Houston, Houston, TX 77054

Labeling: Not Elsewhere Classified: Products may contain synthetic latex and/or natural latex.
FDA

Cardioplegic Solution Maintenance all strengths, all dosage forms and all packaging, Rx Only, Avella of Houston, Houston, TX 77054

Labeling: Not Elsewhere Classified: Products may contain synthetic latex and/or natural latex.
FDA

Potassium Phosphate all strengths, all dosage forms and all packaging, Rx Only, Avella of Houston, Houston, TX 77054

Labeling: Not Elsewhere Classified: Products may contain synthetic latex and/or natural latex.
FDA

Hydromorphone HCl all strengths, all dosage forms and all packaging, Rx Only, Avella of Houston, Houston, TX 77054

Labeling: Not Elsewhere Classified: Products may contain synthetic latex and/or natural latex.
FDA

Norepinephrine Bitartrate all strengths, all dosage forms and all packaging, Rx Only, Avella of Houston, Houston, TX 77054

Labeling: Not Elsewhere Classified: Products may contain synthetic latex and/or natural latex.
FDA

Dexmedetomidine HCl all strengths, all dosage forms and all packaging, Rx Only, Avella of Houston, Houston, TX 77054

Labeling: Not Elsewhere Classified: Products may contain synthetic latex and/or natural latex.
FDA

Fentanyl Citrate with Ropivacaine HCl all strengths, all dosage forms and all packaging, Rx Only, Avella of Houston, Houston, TX 77054

Labeling: Not Elsewhere Classified: Products may contain synthetic latex and/or natural latex.
FDA

NOVA PeriCapsular injection all strengths, all dosage forms and all packaging, Rx Only, Avella of Houston, Houston, TX 77054

Labeling: Not Elsewhere Classified: Products may contain synthetic latex and/or natural latex.
FDA

Morphine Sulfate all strengths, all dosage forms and all packaging, Rx Only, Avella of Houston, Houston, TX 77054

Labeling: Not Elsewhere Classified: Products may contain synthetic latex and/or natural latex.
FDA

Infant 25% DEXTROSE Injection, USP, 2.5 g (250 mg/mL), 10 mL Unit of Use Single-dose Syringe per carton, Rx only, Hospira Inc., Lake Forest, IL 60045, NDC 0409-1775-10

Presence of Particulate Matter: human hair found within an internal sample syringe.
FDA

Ketamine HCl all strengths, all dosage forms and all packaging, Rx Only, Avella of Houston, Houston, TX 77054

Labeling: Not Elsewhere Classified: Products may contain synthetic latex and/or natural latex.
FDA

Meperidine HCl all strengths, all dosage forms and all packaging, Rx Only, Avella of Houston, Houston, TX 77054

Labeling: Not Elsewhere Classified: Products may contain synthetic latex and/or natural latex.
FDA

Neostigmine Methylsulfate all strengths, all dosage forms and all packaging, Rx Only, Avella of Houston, Houston, TX 77054

Labeling: Not Elsewhere Classified: Products may contain synthetic latex and/or natural latex.
FDA

Nalbuphine all strengths, all dosage forms and all packaging, Rx Only, Avella of Houston, Houston, TX 77054

Labeling: Not Elsewhere Classified: Products may contain synthetic latex and/or natural latex.
FDA

Esmolol HCl all strengths, all dosage forms and all packaging, Rx Only, Avella of Houston, Houston, TX 77054

Labeling: Not Elsewhere Classified: Products may contain synthetic latex and/or natural latex.
FDA

Atropine Sulfate all strengths, all dosage forms and all packaging, Rx Only, Avella of Houston, Houston, TX 77054

Labeling: Not Elsewhere Classified: Products may contain synthetic latex and/or natural latex.
FDA

Hyland's Baby Teething Tablets [Calcarea Phosporica 6X HPUS, Chamomilla 6X HPUS, Coffea Cruda 6X HPUS, Belladonna 12X HPUS (0.0000000000003% alkaloids, calculated)] Quick-Dissolving Tablets, packaged in a) 40-count bottles (NDC 54973-3127-3) (UPC 3 54973 31273 9); b) 135-count bottles (NDC 54973-3127-1) (UPCs 3 54973 31271 5, 3 54973 31371 2, 3 54973 31481 8); and 250-count bottles (NDC 54973-3127-2) (UPCs 3 54973 31272 2, 3 54973 31521 1), Manufactured for: Hyland's, Inc., Los Angeles, CA 9006

Superpotent Drug: FDA analysis found inconsistent amounts of belladonna alkaloids that may differ from the calculated amount on the product labels.
FDA

Ofirmev (Acetaminophen) injection all strengths, all dosage forms and all packaging, Rx Only, Avella of Houston, Houston, TX 77054

Labeling: Not Elsewhere Classified: Products may contain synthetic latex and/or natural latex.
FDA

RECK PeriCapsular injection all strengths, all dosage forms and all packaging, Rx Only, Avella of Houston, Houston, TX 77054

Labeling: Not Elsewhere Classified: Products may contain synthetic latex and/or natural latex.
FDA

Ropi/ Epi/ Clon PeriCapsular injection all strengths, all dosage forms and all packaging, Rx Only, Avella of Houston, Houston, TX 77054

Labeling: Not Elsewhere Classified: Products may contain synthetic latex and/or natural latex.
FDA

Calcium Gluconate all strengths, all dosage forms and all packaging, Rx Only, Avella of Houston, Houston, TX 77054

Labeling: Not Elsewhere Classified: Products may contain synthetic latex and/or natural latex.
FDA

Gentamicin Sulfate all strengths, all dosage forms and all packaging, Rx Only, Avella of Houston, Houston, TX 77054

Labeling: Not Elsewhere Classified: Products may contain synthetic latex and/or natural latex.
FDA

Ropivacaine HCl in 0.9% Sodium Chloride all strengths, all dosage forms and all packaging, Rx Only, Avella of Houston, Houston, TX 77054

Labeling: Not Elsewhere Classified: Products may contain synthetic latex and/or natural latex.
FDA

Nitroglycerin all strengths, all dosage forms and all packaging, Rx Only, Avella of Houston, Houston, TX 77054

Labeling: Not Elsewhere Classified: Products may contain synthetic latex and/or natural latex.
FDA

Epinephrine HCl all strengths, all dosage forms and all packaging, Rx Only, Avella of Houston, Houston, TX 77054

Labeling: Not Elsewhere Classified: Products may contain synthetic latex and/or natural latex.
FDA

Norethindrone Acetate and Ethinyl Estradiol Tablets, USP, 1 mg/0.02 mg, 1 blister pack containing 21 tablets (NDC 0378-7280-85), packaged in 3 pouches, each contains one blister pack of 21 tablets (NDC 0378-7280-53), Rx only, Manufactured for: Mylan Pharmaceuticals Inc., Morgantown, WV 26505 U.S.A., Made in India.

Chemical Contamination: out of specification results for impurities were found to be the result of contamination of product from vapors associated with paint thinner used in repair of the manufacturing room.
FDA

Estrone, For Prescription Compounding, packaged in a) 1 G bottle (NDC: 51552-0445-1), b) 5 G bottle (NDC 51552-0445-2), c) 25 G bottle (NDC: 51552-0445-4), d) 100 G bottle (NDC: 51552-0445-5), RX only, Distributed by Fagron, Inc. 2400 Pilot Knob Rd, St. Paul, MN 55120 Tel. 1-(800) 423-6967 Also packaged as: Estrone USP, For Prescription Compounding, packaged in a) 1 G bottle (NDC 52372-9494-01), b) 5 G bottle (NDC 52372-9494-05), c) 25 G bottle (NDC 52372-9494-03), d) 100 G bottle ( NDC 5

cGMP Deviations: lack of quality assurance at the API manufacturer.
FDA

Succinylcholine Chloride all strengths, all dosage forms and all packaging, Rx Only, Avella of Houston, Houston, TX 77054

Labeling: Not Elsewhere Classified: Products may contain synthetic latex and/or natural latex.