Class II · Moderate risk Terminated
Hydrocortisone Ointment USP 1% Maximum Strength Net Wt. 1 oz
Reason CGMP Deviations: Intermittent exposure to temperature excursion during storage.
EVOLVE BEE POLLEN Capsules
Class I — High risk. Reasonable probability of serious harm or death.
Why it was recalled
Marketed Without An Approved NDA/ANDA: tainted product marketed as a dietary supplement. Product found to be tainted with undeclared sibutramine, an appetite suppressant that was withdrawn from the US market for safety reasons, and phenolphthalein, an ingredient found in over-the-counter laxative products that was withdrawn from the US market due to concerns of carcinogenicity, making it an unapproved drug.
What was recalled
EVOLVE BEE POLLEN Capsules, 250mg, 60-count bottles, Manufactured for 2637 E. Atlantic Blvd, Pompano Beach, Florida, 33062 WWW.BEEEXTREMELYAMAZED.COM
- Recalling firm
- Bee Extremely Amazed LLC
- Origin
- OH, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-1140-2016
What should you do? A recall doesn't always mean your specific bottle is affected - it often applies to certain lots only. Check the lot number on your package against the FDA notice, and talk to your pharmacist before stopping any medication.
Other Atlantic recalls
See all
Class III · Low risk Terminated
Clindamycin Phosphate Topical Solution USP
Reason CGMP Deviations: an expired active ingredient was used in the manufacture of these recalled lots.
Class III · Low risk Terminated
Acetasol HC
Reason Failed Impurities/Degradation Specifications: Out of specification (OOS) results for related compound G were obtained at 12-month (at expiry) stability time-point for room temperature sample(s).
Class III · Low risk Terminated
buPROPion Hydrochloride Extended-Release Tablets
Reason Failed Dissolution Specifications: This recall is an extension of the recall initiated on 07/31/2013 for Bupropion HCl Extended-Release Tablets (XL) 300 mg, because another lot was shown to have similar failing results for dissolution at the 8-hour timepoint.
Class III · Low risk Terminated
BuPROPion Hydrochloride Extended-Release Tablets
Reason Failed Dissolution Specifications: Dissolution test results at 8 hour time-point were above approved specification limits.
Get an alert if your medication is recalled
Tell us which medications you take. If the FDA recalls one, we email you - in plain English, with what to do. Free.