Class II · Moderate risk
Bicillin L-A
CGMP Deviations; particulates identified during visual inspection
Penicillin V Potassium for Oral Solution
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Why it was recalled
Subpotent
Cause type: Wrong potency / content
Sub- or super-potent product, or a failed content-uniformity / assay test. You may receive too little or too much active ingredient - a direct dosing risk. All wrong potency / content recalls.
What was recalled
Penicillin V Potassium for Oral Solution, USP 125 mg (200,000 U) per 5 mL a) 100 mL (NDC 00093-4125-73) and b) 200 mL (NDC 00093-4125-74) (when mixed) bottles, Rx Only, Manufactured For: Teva Pharmaceuticals USA, Inc. North Wales, PA 19454
Affected NDCs
0093-4125-73
0093-4125-74
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 00093-4125 |
125 mg/5mL | Powder, for Solution Oral |
Teva Pharmaceuticals USA, Inc. | Rx |
- Recalling firm
- Teva Pharmaceuticals USA
- NDC code
- 00093-4125-73
- Origin
- NJ, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0294-2022 · FDA notice
Check, then ask. Class II means harm is possible but usually temporary or reversible. Find the lot number on your package; if it matches, ask your pharmacist about a replacement. Do not simply stop a prescribed medication on your own - the gap can be riskier than the recall. 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 POT for Oral Solution
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Other recalls by Teva Pharmaceuticals USA
All 2021 recalls
Class II · Moderate risk
traZODone Hydrochloride Tablets
Presence of Foreign Tablets/Capsules
Class II · Moderate risk
Octreotide Acetate for Injectable Suspension
Lack of Assurance of Sterility: Quality system deficiencies identified during a routine U.S Food and Drug Administration (FDA) inspection at the contract manufacturer.
Class II · Moderate risk
Claravis (isotretinoin capsule, USP)
Failed Impurities/Degradation Specifications: Out of specification for specific impurity Tretinoin
Class II · Moderate risk
Clonidine Transdermal System
CGMP Deviations: use of an unapproved raw material
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