SUN PHARMACEUTICAL INDUSTRIES INC recalls Norepinephrine Bitartrate Injection, USP, 4 mg/4 mL* (1 mg/mL), 4 mL Single-dose Fliptop Vial (NDC 47335-615-40); packaged in…
Failed Impurities/Degradation Specifications: Above the specification limits yielded for related substance norepinephrine sulfonic acid impurity during routine product monitoring.
Read the official notice →- Date
- 2023-04-19
- Country
- United States
- Brand
- Sun Pharmaceutical Industries
- Product
- Norepinephrine Bitartrate Injection, USP, 4 mg/4 mL* (1 mg/mL), 4 mL Single-dose Fliptop Vial (NDC 47335-615-40); packaged in 10 x 4 mL…
- Classification
- Class III
- Units
- Nationwide in the USA
- Category
- Drugs & medical
- Source
- FDA · Drug
Copied automatically from the US Food and Drug Administration. Details may be shortened or out of date; the official notice is the authoritative source. Disclaimer
What to do
- Check the product name, strength and lot number against the official notice.
- Do not stop a prescribed medicine without talking to your doctor or pharmacist first.
- Ask the pharmacy or supplier about a replacement or refund.
General guidance from Recall Atlas. The official notice from the US Food and Drug Administration has the exact models, batch codes and remedy, and it takes priority.
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USSUN PHARMACEUTICAL INDUSTRIES INC recalls Buprenorphine Sublingual Tablets, 8 mg, 30 count-bottles, Rx only, Manufactured by: Sun Pharma, NDC 62756-460-83.
CGMP Deviations
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Failed Dissolution Specifications; during stability testing
- 2023-05-03
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Presence of Particulate Matter: A piece of glass was found in a prefilled syringe.
- 2023-03-29
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- 2023-02-08
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SUN PHARMACEUTICAL INDUSTRIES INC recalls Diltiazem Hydrochloride Extended-Release Capsules, USP, 360 mg; Rx only; 90-count bottles, Manufactured by: Sun Pharmaceutical…
Failed Impurity (Deacetyl Diltiazem Hydrochloride) specification during stability testing and failed dissolution testing at FDA laboratory.
- 2022-12-28
- US
Other drugs & medical recalls in the United States
- 2023-04-19
- US
Pfizer Inc. recalls MEKTOVI (binimetinib) tablets, 15 mg, 180-count bottle, Rx only, Distributed by: Array BioPharma Inc., a wholly owned subsidiary of Pfizer…
Labeling: Incorrect or Missing Lot and/or Exp Date: The carton and bottle labels state an expiry date of March 2026; the correct expiration date is February 2025.
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Pine Pharmaceuticals, LLC recalls Bevacizumab 2.5 mg/0.1 mL, Solution for Injection in 1mL, silicone free slip tip syringe, each Syringe supplied in individually labeled…
Labeling: Incorrect or Missing Lot and/or Exp Date: Lot code on primary packaging is incorrect.
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Abbott Molecular, Inc. recalls Abbott Alinity m System, REF 08N53-002, containing Amplification Detetction Unit (ADU) #4.
The instrument was found to be installed without plunger assemblies in the clamp bar for an Amplification Detection Unit. After correction of the issue, the instrument was returned for use without calibration. This…
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CooperSurgical, Inc. recalls Global Total LP single step medium, 60mL, bicarbonate-buffered media for D1-5 embryo culture and transfer, Reference Number H5GT-060
It has come to CooperSurgical's attention that the affected Product may contain a medium other than the Global Total LP single step medium which does not contain the protein source required for embryo culture and…
FDA · DeviceCooperSurgical, Inc.Worldwide - US Nationwide distribution in the states of NY, UT and the…Official notice → - US
Terumo Cardiovascular Systems Corporation recalls CAPIOX NX19 Hollow Fiber Oxygenator, Catalog Number 3CX*NX19RE
Some Capiox NX, RX and FX Oxygenators may contain an arterial thermistor component that is improperly bonded to the oxygenator port. This may result in a leak at the point where the arterial thermistor is improperly…
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