Why it was recalled
CGMP Deviations: Products are underdosed or have an incorrect dosage regime.
Product description
Poly-Vent IR, Poly-Vent DM Tablets, Expectorant, Nasal Decongestant, 60 count bottle, OTC, Distributed by: Poly Pharmaceuticals, Quitman, MS 39355, NDC 50991-561-60
Lot numbers, UPCs & expiration codes
Lot# 11F003 Exp 05/13; Lot# 11M007 Exp 11/13; Lot# 12J002 Exp 08/14.
Where it was sold
FL, MS, SC, LA and TX
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-531-2013
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Jan 30, 2013
- FDA report date
- Jun 12, 2013
- Quantity
- 978,092 Bulk Tablets
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- TG United, Inc.
Original FDA data
Every field from FDA enforcement report D-531-2013, exactly as published.
Show all FDA fields
- City
- Brooksville
- State
- FL
- Status
- Terminated
- Country
- United States
- Event ID
- 64188
- Address
- 16275 Aviation Loop Dr
- Code information
- Lot# 11F003 Exp 05/13; Lot# 11M007 Exp 11/13; Lot# 12J002 Exp 08/14.
- Postal code
- 34604-6805
- Report date
- Jun 12, 2013
- Product type
- Drugs
- Recall number
- D-531-2013
- Classification
- Class II
- Recalling firm
- TG United, Inc.
- Product quantity
- 978,092 Bulk Tablets
- Termination date
- Sep 30, 2016
- Reason for recall
- CGMP Deviations: Products are underdosed or have an incorrect dosage regime.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Poly-Vent IR, Poly-Vent DM Tablets, Expectorant, Nasal Decongestant, 60 count bottle, OTC, Distributed by: Poly Pharmaceuticals, Quitman, MS 39355, NDC 50991-561-60
- Distribution pattern
- FL, MS, SC, LA and TX
- Recall initiation date
- Jan 30, 2013
- Initial firm notification
- Letter
- Center classification date
- Jun 4, 2013