Why it was recalled
Does Not Meet Monograph: NEW GPC INC. has recalled multiple Over-the-Counter Drug Products due to lack of drug listing, lack of OTC drug labeling requirements and labeled Not Approved for sale in U.S.A..
Product description
Ferrol EXPECTORANT, Net Contents: 100 mL. Product packaged within a plastic bottle individually placed in small blue carton. Manufactured by: NEW GPC INC. A1 Farm, EBD. Country of Origin Guyana.
Lot numbers, UPCs & expiration codes
Batch Numbers: 305206
Where it was sold
New York
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
- D0032-2015
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Aug 7, 2014
- FDA report date
- Oct 29, 2014
- Quantity
- 36 units
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- New Gpc Inc.
Original FDA data
Every field from FDA enforcement report D0032-2015, exactly as published.
Show all FDA fields
- City
- East Bank Demerara
- Status
- Terminated
- Country
- Guyana
- Event ID
- 69206
- Address
- Lot A1, Farm
- Code information
- Batch Numbers: 305206
- Report date
- Oct 29, 2014
- Product type
- Drugs
- Recall number
- D0032-2015
- Classification
- Class II
- Recalling firm
- New Gpc Inc.
- Product quantity
- 36 units
- Termination date
- Jun 4, 2018
- Reason for recall
- Does Not Meet Monograph: NEW GPC INC. has recalled multiple Over-the-Counter Drug Products due to lack of drug listing, lack of OTC drug labeling requirements and labeled Not Approved for sale in U.S.A..
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Ferrol EXPECTORANT, Net Contents: 100 mL. Product packaged within a plastic bottle individually placed in small blue carton. Manufactured by: NEW GPC INC. A1 Farm, EBD. Country of Origin Guyana.
- Distribution pattern
- New York
- Recall initiation date
- Aug 7, 2014
- Initial firm notification
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Center classification date
- Oct 17, 2014