Class II · Moderate risk
Bicillin L-A
CGMP Deviations; particulates identified during visual inspection
Penicillin V Potassium Tablets
Class III — Low risk. Unlikely to cause harm, but violates FDA regulations.
Why it was recalled
Presence of Foreign Tablet/Capsule; Amoxicillin 500 mg was found in bottles of Penicillin V potassium 500 mg
Cause type: Cross-contamination
Traces of another drug - most often penicillin - got into the product from shared equipment or facilities. Even trace penicillin can trigger a severe allergic reaction in someone who was never meant to receive it. All cross-contamination recalls.
What was recalled
Penicillin V Potassium Tablets, USP 500 mg (800,000 units) 1000 count bottles, Rx Only, Distributed by: Citron Pharma LLC, East Brunswick, NJ --- NDC 57237-041-99
Affected NDC
57237-0041-99
Compare with the code on your package — it is the most precise check available.
Drug: Penicillin Category: Antibiotic
Product details
From the FDA NDC directory, for the product code this recall names. Compare with the label on your package.
| Product | Strength | Form & route | Labeler | Type |
|---|---|---|---|---|
| Penicillin V Potassium NDC 57237-0041 |
500 mg/1 | Tablet, Film Coated Oral |
Rising Health, LLC | Rx |
- Recalling firm
- Citron Pharma Llc
- NDC code
- 57237-041-99
- Origin
- NJ, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0652-2017 · FDA notice
Low risk, still worth a check. Class III means the product is unlikely to cause harm but breaks an FDA rule (often labeling). If your lot matches, your pharmacy will normally swap it; there is no need for alarm. This recall is now terminated, which means the firm has finished removing the affected product; anything on pharmacy shelves today should be unaffected.
Other Penicillin recalls
See all
Class I · High risk
Buffered Penicillin G Potassium for Injection
Labeling: Label Mix-Up; Some vials of Cefazolin for Injection, USP 1 gram were incorrectly labeled as penicillin G potassium for Injection, USP, 20 million Unit
Class II · Moderate risk
Bicillin L-A
cGMP Deviations: Products were stored outside the drug label specifications.
Class II · Moderate risk
Penicillin
Lack of sterility assurance
Class II · Moderate risk
Penicillin V Potassium for Oral Solution
Subpotent
Other cross-contamination recalls from 2017
All cross-contamination recalls
Class II · Moderate risk
Divalproex Sodium Delayed Release Tablets USP
Cross Contamination With Other Products: metronidazole powder was found in one bottle of Divalproex Sodium.
Class III · Low risk
Fluocinonide Gel USP
Cross contamination with other products: traces of Dapsone were found in the finished product.
Class II · Moderate risk
Nose to Toes Skin Antisepsis
Cross Contamination With Other Products: Oral care solutions were manufactured by a third party supplier on equipment shared with non-pharmaceutical products
Class II · Moderate risk
Skin antisepsis and oral cleansing. Contains Three 2-packs of 2%…
Cross Contamination With Other Products: Oral care solutions were manufactured by a third party supplier on equipment shared with non-pharmaceutical products
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