Class II · Moderate risk
Theraflu Cough Relief
Labeling: Label Lacks Warning: Product recalled due to absence of a warning statement on the product label, Ask a doctor before use if you have a sodium-restricted diet.
Quinacrine Dihydrochloride
Class I — High risk. Reasonable probability of serious harm or death.
Why it was recalled
Label Mix-Up: Product labeled as Quinacrine Dihydrochloride; however, after testing, identified as Artemisinin.
Cause type: Labeling / mix-up
Wrong label, wrong strength, mixed-up products, or packaging errors. One of the most dangerous causes - you can end up taking the wrong drug or the wrong dose. All labeling / mix-up recalls.
What was recalled
Quinacrine Dihydrochloride (98.25%), bulk API product, packaged in a) 500 g NDC# 71052-530-05; b) 50 g NDC# 71052-530-55, c) 25g NDC# 71052-530-25, Darmerica LLC 198 Wilshire Blvd Casselberry, FL 32707
Affected NDCs
71052-0530-05
71052-0530-25
71052-0530-55
Compare with the code on your package — it is the most precise check available.
- Recalling firm
- Darmerica, LLC
- NDC code
- 71052-530-05
- Origin
- FL, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0125-2020 · FDA notice
Treat this as urgent. Class I means FDA judged there is a reasonable probability of serious harm. Find the lot number on your package; if it matches the recalled lots, do not take another dose before you have spoken to your pharmacist or prescriber - today, not next week. This recall is now terminated, which means the firm has finished removing the affected product; anything on pharmacy shelves today should be unaffected.
Other labeling / mix-up recalls from 2019
All labeling / mix-up recalls
Class II · Moderate risk
Testosterone Topical Cream 4%
Labeling: Incorrect or missing lot and/or expiration date. Products were compounded using expired components.
Class II · Moderate risk
Tadalafil 6 mg Capsule
Labeling: Incorrect or missing lot and/or expiration date. Products were compounded using expired components.
Class II · Moderate risk
Tadalafil 20 mg Troche
Labeling: Incorrect or missing lot and/or expiration date. Products were compounded using expired components.
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