Why it was recalled
Marketed Without An Approved NDA/ANDA: presence of undeclared morphine.
Product description
Licorice Coughing Liquid (guaifenesin), 5%, 3.38 fl. oz. (100 ml), OTC, Manufactured by: Ma Ying Long Pharmaceutical Group Co., LTD, Wuhan, China; Distributed by: Master Herbs (USA) Inc., NDC 68511-0460-01
Lot numbers, UPCs & expiration codes
all lots
Where it was sold
Nationwide
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-0908-2016
- Classification
- Class I
- Status
- Terminated
- Recall initiated
- Jan 15, 2016
- FDA report date
- Jun 1, 2016
- Quantity
- 6024 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Master Herbs, Inc./Li
Original FDA data
Every field from FDA enforcement report D-0908-2016, exactly as published.
Show all FDA fields
- City
- Pomona
- State
- CA
- Status
- Terminated
- Country
- United States
- Event ID
- 73102
- Address
- 1452 W Holt Ave
- Code information
- all lots
- Postal code
- 91768-2832
- Report date
- Jun 1, 2016
- Product type
- Drugs
- Recall number
- D-0908-2016
- Classification
- Class I
- Recalling firm
- Master Herbs, Inc./Li
- Product quantity
- 6024 bottles
- Termination date
- Feb 7, 2017
- Reason for recall
- Marketed Without An Approved NDA/ANDA: presence of undeclared morphine.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Licorice Coughing Liquid (guaifenesin), 5%, 3.38 fl. oz. (100 ml), OTC, Manufactured by: Ma Ying Long Pharmaceutical Group Co., LTD, Wuhan, China; Distributed by: Master Herbs (USA) Inc., NDC 68511-0460-01
- Distribution pattern
- Nationwide
- Recall initiation date
- Jan 15, 2016
- Initial firm notification
- Press Release
- Center classification date
- May 26, 2016