Class III · Low risk
Hyoscyamine Sulfate Sublingual Tablets
Chemical Contamination: Bottles may contain broken dessicants
VP-CH-PNV Prenatal/Postnatal capsules
Class III — Low risk. Unlikely to cause harm, but violates FDA regulations.
Why it was recalled
Defective delivery system: Softgel capsules are leaking.
Cause type: Packaging defect
Failed child-resistant closures, leaks, cracked containers, or a defective delivery device. Packaging failures risk accidental exposure (especially to children) or product contamination. All packaging defect recalls.
What was recalled
VP-CH-PNV Prenatal/Postnatal capsules, prenatal supplement, 30-count bottle, Rx only, Manufactured for: Virtus Pharmaceuticals, LLC, Tampa, FL 33619, NDC 69543-224-30
Affected NDC
69543-0224-30
Compare with the code on your package — it is the most precise check available.
- Recalling firm
- Virtus Pharmaceuticals, Llc
- NDC code
- 69543-224-30
- Origin
- FL, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-1048-2016 · 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 recalls by Virtus Pharmaceuticals, Llc
All 2016 recalls
Class III · Low risk
Virt-Nate Prenatal/Postnatal
Tablets/Capsules Imprinted with Wrong ID; product debossed with an incorrect punch. Bottles could contain tablets debossed with V259 (debossing for PreTab) instead of the correct punch, V264 (debossing for Virt-Nate).
Class III · Low risk
VP-CH-PNV PRENATAL/POSTNATAL Prescription Folic Acid-Containing Dietary Supplement
Defective Delivery System: Product may contain leaking capsules.
Other packaging defect recalls from 2016
All packaging defect recalls
Class III · Low risk
Azelastine Hydrochloride Nasal Solution
Defective Delivery System: out of specification result for droplet size distribution at the d90 measurement testing during the 6 month time point..
Class I · High risk
GlucaGen HypoKit
Defective delivery system: detached needles on the syringe in the kit.
Class III · Low risk
Varithena (polidocanol injectable foam)
Defective Delivery System: Incorrect type of syringe found in commercially distributed administration pack
Class II · Moderate risk
Transderm Scop
Defective Delivery System; reports of damaged product that may alter the predicted release of scopolamine following transdermal application.
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