SUN PHARMACEUTICAL INDUSTRIES INC recalls Testosterone Cypionate Injection, USP, 200 mg/mL, 1 mL Single-dose vial per carton, Rx only, Distributed by: Sun Pharmaceutical…
Lack of Assurance of Sterility: Manufacturing deviation which was reported due to a microbial excursion
Read the official notice →- Date
- 2022-06-29
- Country
- United States
- Brand
- Sun Pharmaceutical Industries
- Product
- Testosterone Cypionate Injection, USP, 200 mg/mL, 1 mL Single-dose vial per carton, Rx only, Distributed by: Sun Pharmaceutical…
- Classification
- Class II
- Units
- Nationwide within the United States
- 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 Details may be shortened or out of date; the official notice is the authoritative source.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.
More Sun Pharmaceutical Industries recalls
- 2022-07-20
US- 2022-07-13
- US
SUN PHARMACEUTICAL INDUSTRIES INC recalls Testosterone Cypionate Injection, USP, 200mg/ml, Rx Only, One Single-dose vial, Distributed by: Sun Pharmaceutical Industries…
CGMP Deviations: Manufacturing deviations were reported due to an abnormal appearance on parts of machinery.
- 2022-06-29
- US
SUN PHARMACEUTICAL INDUSTRIES INC recalls Clonazepam Orally Disintegrating Tablets, USP, 0.125mg, Rx Only, 60 Tablets, Mfd. by: Sun Pharmaceutical Industries Ltd.…
Failed Tablet/Capsule Specification; oversized tablet found in a bottle
- US
SUN PHARMACEUTICAL INDUSTRIES INC recalls Testosterone Cypionate Injection, USP, 200 mg/mL, 1 mL Single-dose vial per carton, Rx only, Distributed by: Sun Pharmaceutical…
CGMP Deviations: lots made with same active pharmaceutical ingredient (API) as lots that were rejected due to manufacturing issues that could cause the product to be out of specification for impurities.
- 2022-06-22
- US
- 2022-05-18
- US
SUN PHARMACEUTICAL INDUSTRIES INC recalls buPROPion Hydrochloride Extended-Release Tablet, USP (SR), 200 mg, 60-count bottle, Rx only Distributed by: Sun Pharmaceutical…
Presence Of Foreign Substance: Customer complaint for the presence of dark, gritty substance found within the bottle which was determined to be activated carbon from the desiccant canister inside the bottle.
Other drugs & medical recalls in the United States
- 2022-06-29
- US
Medtronic Inc recalls HeartWare Battery, Model #1650DE, a component of the HeartWare Ventricular Assist Device (HVAD) System.
Batteries for the HVAD system have a weld defect affecting internal components within the HVAD battery, resulting in the battery to malfunction and no longer provide power or prevent the battery from holding a complete…
FDA · DeviceMedtronic IncWorldwide Distribution. US nationwide, Austria, Belgium, Finland, France,…Official notice → - US
Teva Pharmaceuticals USA Inc recalls Tretinoin Capsules, 10 mg, Rx Only, 100 capsules per bottle, Teva Pharmaceuticals USA Inc., North Wales, PA, 19454, NDC 0555-0808-02.
Failed Dissolution Specifications; Low Out of Specification (OOS) results for dissolution.
- US
SUN PHARMACEUTICAL INDUSTRIES INC recalls Clonazepam Orally Disintegrating Tablets, USP, 0.125mg, Rx Only, 60 Tablets, Mfd. by: Sun Pharmaceutical Industries Ltd.…
Failed Tablet/Capsule Specification; oversized tablet found in a bottle
- US
SUN PHARMACEUTICAL INDUSTRIES INC recalls Testosterone Cypionate Injection, USP, 200 mg/mL, 1 mL Single-dose vial per carton, Rx only, Distributed by: Sun Pharmaceutical…
CGMP Deviations: lots made with same active pharmaceutical ingredient (API) as lots that were rejected due to manufacturing issues that could cause the product to be out of specification for impurities.
- US
Mayne Pharma Inc recalls Clonidine Transdermal System, USP 0.3 mg/day, 4 Patches (NDC 51862-455-01) per Carton (51862-455-04), Rx only, Manufactured for: Mayne…
Defective Delivery System: Out of specification for release liner removal force results at the 3-month CRT stability timepoint.
- US
Vi-Jon, LLC recalls 70% ISOPROPYL ALCOHOL First aid antiseptic, 4 FL OZ (118 mL) bottle, Made in US with US and foreign components for Medline Industries,…
Defective Container: Product may leak when squeezed or when not in an upright position determined to be due to defects in the bottle neck finish and insufficient tightening.