Atlantic Management Resources Ltd. recalls ProSirona, A Homeopathic Formula, Calendula Oil packaged in 1/8 Fl. oz. (3.5 g) bottles, Dist. by: Endometriosis Assoc. Inc.…

cGMP Deviations

Date

2022-12-21

Country

United States

Brand

Atlantic Management Resources

Product

ProSirona, A Homeopathic Formula, Calendula Oil packaged in 1/8 Fl. oz. (3.5 g) bottles, Dist. by: Endometriosis Assoc. Inc.…

Classification

Class II

Units

Nationwide and Australia

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 Details may be shortened or out of date; the official notice is the authoritative source.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

1. Check the product name, strength and lot number against the official notice.
2. Do not stop a prescribed medicine without talking to your doctor or pharmacist first.
3. 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 Atlantic Management Resources recalls

1. 2025-09-17
2. US
   Drugs & medicalClass II

   Atlantic Management Resources Ltd. recalls Neuroquell & Neuroquell Plus, .22 fl. Oz (6.6mL),Mfg. For/Dist. By Claire Ellen Products, P.O. Box 901 Westboro, MA 01581…

   cGMP violations

   FDA · DrugAtlantic Management Resources Ltd.Product was distributed via the internet.Official notice →

Other drugs & medical recalls in the United States

1. 2022-12-21
2. US
   Drugs & medicalClass I

   ARROW INTERNATIONAL Inc. recalls Pressure Injectable Arrowg+ard Blue Plus Three-Lumen CVC Kit, REF numbers: a) ASK-42703-NS, b) ASK-42703-PCCH2, c) ASK-42703-PUPM1, d)…

   There is the potential for inadequate connection between the top and bottom housings of the Micro Clave Clear Connectors included in the Arrow MAC Two-Lumen Central Venous Access Kit and the Arrow Pressure Injectable…

   FDA · DeviceARROW INTERNATIONAL Inc.US Distributor in states of: FL, GA, KY, OH, PA and WV.Official notice →
3. US
   Drugs & medicalClass III

   Camber Pharmaceuticals, Inc recalls Lacosamide Oral Solution, USP, CV, 10mg/mL, packaged in 200 mL bottle, Rx Only, Manufactured for: Camber Pharmaceuticals, Inc.,…

   Failed Excipient Specifications: out of specification result observed for p-Hydroxybenzoic Acid content

   FDA · DrugCamber Pharmaceuticals, IncUSA NationwideOfficial notice →
4. US
   Drugs & medicalClass I

   BayCare Integrated Service Center, LLC /dba BayCare… recalls Iohexol (300 mg Iodine/mL), 2.4 g Iodine/8 ml, Total Volume 8 ml in 10 ml syringe, 5-count syringes…

   Labeling: Label Error on Declared Strength: syringes mislabeled as 300 mg iodine/mL contained product 350 mg iodine/mL

   FDA · DrugBayCare Integrated Service Center, LLC /dba BayCare…BayCare Health System hospitals in FLOfficial notice →
5. US
   Drugs & medicalClass I

   Exela Pharma Sciences LLC recalls 8.4% Sodium Bicarbonate Injection, USP 50 mEq/50 mL (1 mEq/mL) 50 mL Single Dose Vials, packaged in cartons of 20 vials, Rx Only, Mfd…

   Defective Container: Complaints received of vial breakage and glass flying when pressurized while preparing the product for administration.

   FDA · DrugExela Pharma Sciences LLCNationwide within the United StatesOfficial notice →
6. US
   Drugs & medicalClass II

   OurPharma LLC recalls FentaNYL Citrate 2.5 mg/50 mL (50mcg/ml) Injection Solution, Preservative Free, Single Use 50 ml Cassette, Rx Only, Repackaged by…

   Underfilled units.

   FDA · DrugOurPharma LLCMOOfficial notice →
7. 2022-12-14
8. US
   Drugs & medicalClass II

   Arthrex, Inc. recalls Small Joint OATS Set, REF AR-8981-06S, 6mm; and Small Joint OATS Set, REF AR-8981-08S, 8mm, both containing a cannulated reamer, sterile.

   The devices may be packaged with the wrong reamer size.

   FDA · DeviceArthrex, Inc.Distribution was made to AL, AR, CA, CO, FL, IA, IL, LA, MA, MD, MI, NC, NJ,…Official notice →