Recall Atlas
Drugs & medicalClass III

PAI Holdings, LLC. dba Pharmaceutical Associates Inc recalls Guaifenesin and Codeine Phosphate Oral Solution USP, 100mg/10 mg per 5 mL, 16 fl oz (473 ml) bottles, PAI…

Superpotent; sodium benzoate preservative

Read the official notice →
Date
2025-02-12
Country
United States
Brand
PAI Holdings, LLC. dba Pharmaceutical Associates Inc
Product
Guaifenesin and Codeine Phosphate Oral Solution USP, 100mg/10 mg per 5 mL, 16 fl oz (473 ml) bottles, PAI Pharmaceutical Associates, Inc.,…
Classification
Class III
Units
OH
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 Details may be shortened or out of date; the official notice is the authoritative source.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.

Other drugs & medical recalls in the United States

  1. 2025-02-12
  2. US
    Drugs & medicalClass II

    GE Medical Systems, LLC recalls Optima XR646 HD. X-Ray imaging system.

    The user can continue to take the next exposure after reaching the Automatic Exposure Control (AEC) limit, without taking any further actions to acknowledge or adjust exposure techniques. In all cases, a message still…

    FDA · DeviceGE Medical Systems, LLCWorldwide Distribution: US (nationwide) including Puerto Rico and OUS…Official notice →
  3. US
    Drugs & medicalClass I

    Fresenius Kabi USA, LLC recalls Ivenix Infusion System (IIS), LVP Software LVP-SW-0005. Indicated for use in a hospital and in outpatient care environments for the…

    Large Volume Pump Software, version 5.9.2 and earlier has potential for the following anomalies: 1. The pump may become nonfunctional if during an alarm condition the Pause Audio option is repeated 70 time or more. 2.…

    FDA · DeviceFresenius Kabi USA, LLCUS distribution to CA, CO, GA, ID, MI, MS, NE, NJ, NV, OK, TX, UT, VA, WA, WI.Official notice →
  4. US
    Drugs & medicalClass I

    ENDO USA, Inc. recalls Adrenalin Chloride Solution (Epinephrine Nasal Solution, USP), 30mg/30mL (1mg/mL), packaged in 30 mL vials, Distributed by: Par…

    Labeling: Not Elsewhere Classified: misleading label similar in appearance to the FDA-approved drug product Adrenalin¿ (epinephrine injection, USP)

    FDA · DrugENDO USA, Inc.USA nationwide.Official notice →
  5. US
    Drugs & medicalClass II

    The Harvard Drug Group LLC dba Major Pharmaceuticals and… recalls Potassium Chloride Extended-Release Tablets, USP, 10 mEq (750 mg), 100 Tablets per carton (10 x 10…

    Failed Dissolution Specifications.

    FDA · DrugThe Harvard Drug Group LLC dba Major Pharmaceuticals and…Nationwide in the USAOfficial notice →
  6. US
    Drugs & medicalClass II

    SKY PACKAGING recalls HydrALAZINE Hydrochloride, 100 Tablets (10x10), USP, 50mg, Rx only, Manufactured by Strides Pharma Science Ltd, Bengaluru, India,…

    Failed Impurities/Degradation Specifications

    FDA · DrugSKY PACKAGINGNationwide within the United StatesOfficial notice →
  7. US
    Drugs & medicalClass II

    Teva Pharmaceuticals USA, Inc recalls Granix (tbo-filgrastim) Injection 300 mcg/0.5 mL, Single Dose prefilled syringe, packaged as a) 1 syringe in 1 CARTON, NDC…

    Failed Stability Specifications - 12-month stability test result for one of the known peptides is below the specification limit

    FDA · DrugTeva Pharmaceuticals USA, IncProduct was distributed nationwide.Official notice →
See all drugs & medical recalls →