Why it was recalled
Does not meet monograph: product exhibits lead levels in excess of the USP monograph limits.
Product description
Zinc Acetate, Crystal, USP, packaged in 500 gram bottles, Spectrum Chemical MFG, CORP., New Brunswick, NJ 08901
Lot numbers, UPCs & expiration codes
Lot # 2EH0257
Where it was sold
US: MA, TN, GA, MO and Canada
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-1456-2016
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Aug 1, 2016
- FDA report date
- Aug 17, 2016
- Quantity
- 14,000 grams
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Spectrum Laboratory Products, Inc.
Original FDA data
Every field from FDA enforcement report D-1456-2016, exactly as published.
Show all FDA fields
- City
- New Brunswick
- State
- NJ
- Status
- Terminated
- Country
- United States
- Event ID
- 74888
- Address
- 755 and 769 Jersey Ave
- Code information
- Lot # 2EH0257
- Postal code
- 08901-3605
- Report date
- Aug 17, 2016
- Product type
- Drugs
- Recall number
- D-1456-2016
- Classification
- Class II
- Recalling firm
- Spectrum Laboratory Products, Inc.
- Product quantity
- 14,000 grams
- Termination date
- Apr 7, 2017
- Reason for recall
- Does not meet monograph: product exhibits lead levels in excess of the USP monograph limits.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Zinc Acetate, Crystal, USP, packaged in 500 gram bottles, Spectrum Chemical MFG, CORP., New Brunswick, NJ 08901
- Distribution pattern
- US: MA, TN, GA, MO and Canada
- Recall initiation date
- Aug 1, 2016
- Initial firm notification
- Letter
- Center classification date
- Aug 10, 2016