FDA Recall
TerminatedTerminated: October 18, 2017Historical recordClass II
Ofirmev (Acetaminophen) injection all strengths, all dosage forms and all packaging, Rx Only, Avella of Houston, Houston, TX 77054
by Advanced Pharma Inc.
- Reason
- Labeling: Not Elsewhere Classified: Products may contain synthetic latex and/or natural latex.
- Published
- May 31, 2017
- Distribution
- Nationwide
View recall →
FDA Recall
OngoingHistorical recordClass II
Ventolin HFA (albuterol sulfate) Inhalation, 90 mcg per actuation, 200 Metered Inhalations, Net Wt. 18 g inhalers, Rx only, GlaxoSmithKline, Research Triangle Park, NC 27709, NDC 0173-0682-20.
by GlaxoSmithKline, LLC
- Reason
- Defective Delivery System: Elevated number of units with out of specification results for leak rate
- Published
- May 31, 2017
- Distribution
- Nationwide
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FDA Recall
TerminatedTerminated: June 18, 2019Historical recordClass II
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
by Cell Distributors
- Reason
- Labeling: Not elsewhere classified; product labeling lacks a NDC number, net weight information and does not contain the Drug Facts Panel.
- Published
- May 31, 2017
- Distribution
- Nationwide
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FDA Recall
TerminatedTerminated: October 26, 2017Historical recordClass I
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 90061.
by Standard Homeopathic Company
- Reason
- Superpotent Drug: FDA analysis found inconsistent amounts of belladonna alkaloids that may differ from the calculated amount on the product labels.
- Published
- May 31, 2017
- Distribution
- Nationwide
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FDA Recall
OngoingHistorical recordClass I
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
by Hospira Inc.
- Reason
- Presence of Particulate Matter: human hair found within an internal sample syringe.
- Published
- May 31, 2017
- Distribution
- Nationwide
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FDA Recall
TerminatedTerminated: June 1, 2017Historical recordClass III
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.
by Mylan Pharmaceuticals Inc.
- Reason
- 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.
- Published
- May 31, 2017
- Distribution
- Nationwide
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FDA Recall
TerminatedTerminated: June 1, 2017Historical recordClass III
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.
by Mylan Pharmaceuticals Inc.
- Reason
- 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.
- Published
- May 31, 2017
- Distribution
- Nationwide
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FDA Recall
TerminatedTerminated: December 22, 2017Historical recordClass III
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
by STRIDES PHARMA INC
- Reason
- Failed Stability Specifications: Out of Specification results obtained for preservative Methylparaben content.
- Published
- May 31, 2017
- Distribution
- Nationwide
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FDA Recall
TerminatedTerminated: October 18, 2017Historical recordClass II
Fentanyl Citrate and Bupivacaine HCl all strengths, all dosage forms and all packaging, Rx Only, Avella of Houston, Houston, TX 77054
by Advanced Pharma Inc.
- Reason
- Labeling: Not Elsewhere Classified: Products may contain synthetic latex and/or natural latex.
- Published
- May 31, 2017
- Distribution
- Nationwide
View recall →
FDA Recall
TerminatedTerminated: October 18, 2017Historical recordClass II
Fentanyl Citrate with Ropivacaine HCl all strengths, all dosage forms and all packaging, Rx Only, Avella of Houston, Houston, TX 77054
by Advanced Pharma Inc.
- Reason
- Labeling: Not Elsewhere Classified: Products may contain synthetic latex and/or natural latex.
- Published
- May 31, 2017
- Distribution
- Nationwide
View recall →
FDA Recall
TerminatedTerminated: October 18, 2017Historical recordClass II
Sodium Citrate all strengths, all dosage forms and all packaging, Rx Only, Avella of Houston, Houston, TX 77054
by Advanced Pharma Inc.
- Reason
- Labeling: Not Elsewhere Classified: Products may contain synthetic latex and/or natural latex.
- Published
- May 31, 2017
- Distribution
- Nationwide
View recall →
FDA Recall
TerminatedTerminated: October 18, 2017Historical recordClass II
Potassium Phosphate all strengths, all dosage forms and all packaging, Rx Only, Avella of Houston, Houston, TX 77054
by Advanced Pharma Inc.
- Reason
- Labeling: Not Elsewhere Classified: Products may contain synthetic latex and/or natural latex.
- Published
- May 31, 2017
- Distribution
- Nationwide
View recall →
FDA Recall
TerminatedTerminated: October 18, 2017Historical recordClass II
Magnesium Sulfate all strengths, all dosage forms and all packaging, Rx Only, Avella of Houston, Houston, TX 77054
by Advanced Pharma Inc.
- Reason
- Labeling: Not Elsewhere Classified: Products may contain synthetic latex and/or natural latex.
- Published
- May 31, 2017
- Distribution
- Nationwide
View recall →
FDA Recall
TerminatedTerminated: October 18, 2017Historical recordClass II
Cardioplegic Solution Maintenance all strengths, all dosage forms and all packaging, Rx Only, Avella of Houston, Houston, TX 77054
by Advanced Pharma Inc.
- Reason
- Labeling: Not Elsewhere Classified: Products may contain synthetic latex and/or natural latex.
- Published
- May 31, 2017
- Distribution
- Nationwide
View recall →
FDA Recall
TerminatedTerminated: October 18, 2017Historical recordClass II
Dexmedetomidine HCl all strengths, all dosage forms and all packaging, Rx Only, Avella of Houston, Houston, TX 77054
by Advanced Pharma Inc.
- Reason
- Labeling: Not Elsewhere Classified: Products may contain synthetic latex and/or natural latex.
- Published
- May 31, 2017
- Distribution
- Nationwide
View recall →
FDA Recall
TerminatedTerminated: October 18, 2017Historical recordClass II
Ondansetron HCl all strengths, all dosage forms and all packaging, Rx Only, Avella of Houston, Houston, TX 77054
by Advanced Pharma Inc.
- Reason
- Labeling: Not Elsewhere Classified: Products may contain synthetic latex and/or natural latex.
- Published
- May 31, 2017
- Distribution
- Nationwide
View recall →
FDA Recall
TerminatedTerminated: October 18, 2017Historical recordClass II
Famotidine HCl all strengths, all dosage forms and all packaging, Rx Only, Avella of Houston, Houston, TX 77054
by Advanced Pharma Inc.
- Reason
- Labeling: Not Elsewhere Classified: Products may contain synthetic latex and/or natural latex.
- Published
- May 31, 2017
- Distribution
- Nationwide
View recall →
FDA Recall
TerminatedTerminated: October 18, 2017Historical recordClass II
Betamethasone Sodium Phosphate & Betamethasone Acetate all strengths, all dosage forms and all packaging, Rx Only, Avella of Houston, Houston, TX 77054
by Advanced Pharma Inc.
- Reason
- Labeling: Not Elsewhere Classified: Products may contain synthetic latex and/or natural latex.
- Published
- May 31, 2017
- Distribution
- Nationwide
View recall →
FDA Recall
TerminatedTerminated: October 18, 2017Historical recordClass II
Atropine Sulfate all strengths, all dosage forms and all packaging, Rx Only, Avella of Houston, Houston, TX 77054
by Advanced Pharma Inc.
- Reason
- Labeling: Not Elsewhere Classified: Products may contain synthetic latex and/or natural latex.
- Published
- May 31, 2017
- Distribution
- Nationwide
View recall →
FDA Recall
TerminatedTerminated: October 18, 2017Historical recordClass II
Neostigmine Methylsulfate all strengths, all dosage forms and all packaging, Rx Only, Avella of Houston, Houston, TX 77054
by Advanced Pharma Inc.
- Reason
- Labeling: Not Elsewhere Classified: Products may contain synthetic latex and/or natural latex.
- Published
- May 31, 2017
- 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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