Monarch PCM, LLC recalls Phenobarbital Elixir, USP 20 mg/5 mL, 1 Pint (473 mL) bottles, Rx Only, Manufactured for: Westminster Pharmaceuticals, LLC Tampa, FL…
Does Not Meet USP or OTC Monograph: Product exceeds USP specification for alcohol content
Read the official notice →- Date
- 2022-05-25
- Country
- United States
- Brand
- Monarch PCM
- Product
- Phenobarbital Elixir, USP 20 mg/5 mL, 1 Pint (473 mL) bottles, Rx Only, Manufactured for: Westminster Pharmaceuticals, LLC Tampa, FL…
- Classification
- Class III
- Units
- TN only
- 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 Details may be shortened or out of date; the official notice is the authoritative source.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 Monarch PCM recalls
- 2021-10-06
USMonarch PCM, LLC recalls Ferretts IPS Iron Liquid Dietary Supplement Iron Protein Succinylate 40 mg (elemental iron) / 15 mL 8 oz. White Round PET 24/410 bottle
Stability is out of spec at 81% for 3 month time period.
- US
Monarch PCM, LLC recalls Hydroquinone USP, 4% Skin Bleaching Cream, Rx only, Net Wt 1 oz (28.35g), Manufactured for: Westminster Pharmaceuticals, LLC Nashville, TN…
Finished product specification did not meet USP specifications.
Other drugs & medical recalls in the United States
- 2022-05-25
- US
Apotex Corp. recalls Sirolimus Oral Solution, 1 mg/mL, 60 mL bottle, Rx Only, Manufactured by: Apotex Inc. Toronto, Ontario Canada M9L 1T9 Manufactured for:…
Failed Dissolution Specifications: Sirolimus Oral Solution recalled due to lot RZ1598 exceeded the specification limit at the 14-month timepoint.
- US
American Health Packaging recalls Nitrofurantoin Capsules, USP (Monohydrate/Macrocrystals), 100 mg, 100 Capsules (10 x 10), 10-count blisters per card, 10 cards per…
Failed Dissolution Specifications: Nitrofurantoin Capsules recalled due to dissolution failure at 0-time of the repackaged lot. Drug release results were above specification at 0-time.
- US
Bestco LLC recalls Open Nature Cough Drops Menthol-Cough Suppressant/Oral Anesthetic Peppermint Naturally Flavored, packaged in Bags of 30 lozenges,…
Subpotent drug: Low OOS for menthol content at the three month room temperature.
- US
Lupin Pharmaceuticals Inc. recalls GaviLyte -C (Polyethylene Glycol 3350, 240 g) and electrolytes for Oral Solution, USP with flavor pack NDC# 43386-060-19
Failed Stability Specification
FDA · DrugLupin Pharmaceuticals Inc.Product was distributed nationwide, including Puerto Rico.Official notice → - US
Pfizer Inc. recalls Accupril (Quinapril HCl Tablets) 10 mg, 90 Tablets Rx only NDC 0071-0530-23 Distributed by: Parke-Davis Division of Pfizer Inc. NY, NY 10017
CGMP Deviations: Contains N-nitrosoquinapril above the acceptable limits.
- US
Plastikon Healthcare LLC recalls Acetaminophen Oral Solution, USP 650mg/ 20.3 mL cup, packaged in 10 cups per tray, 10 trays per carton, For Institutional Use Only,…
CGMP Deviations: Failure to properly investigate failed microbial testing.
FDA · DrugPlastikon Healthcare LLCDistributed in Indiana for further distribution in the USA.Official notice →