Why it was recalled
Subpotent Drug
Product description
Atropine Sulfate Injection Solution, 0.4 mg/1 mL (0.4 mg/mL), in a) 1 mL syringes and b) 2 mL syringes, Rx Only, Cantrell Drug Co., Little Rock, AR --- NDC 52533-010-45, UPC: 0100352533010453
Lot numbers, UPCs & expiration codes
a) Lots: 149690, exp 9/14/15 and 151665, exp 11/5/15 and b) Lots: 149198, exp 9/3/15; 151454, exp 9/14/15; 151668, exp 11/5/15 and 151962, exp 11/11/15
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-1153-2016
- Classification
- Class I
- Status
- Terminated
- Recall initiated
- Aug 21, 2015
- FDA report date
- Jul 13, 2016
- Quantity
- a) 450 syringes and b) 1250 syringes
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Cantrell Drug Company
Original FDA data
Every field from FDA enforcement report D-1153-2016, exactly as published.
Show all FDA fields
- City
- Little Rock
- State
- AR
- Status
- Terminated
- Country
- United States
- Event ID
- 72028
- Address
- 7321 Cantrell Rd
- Code information
- a) Lots: 149690, exp 9/14/15 and 151665, exp 11/5/15 and b) Lots: 149198, exp 9/3/15; 151454, exp 9/14/15; 151668, exp 11/5/15 and 151962, exp 11/11/15
- Postal code
- 72207-4144
- Report date
- Jul 13, 2016
- Product type
- Drugs
- Recall number
- D-1153-2016
- Classification
- Class I
- Recalling firm
- Cantrell Drug Company
- Product quantity
- a) 450 syringes and b) 1250 syringes
- Termination date
- Feb 3, 2017
- Reason for recall
- Subpotent Drug
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Atropine Sulfate Injection Solution, 0.4 mg/1 mL (0.4 mg/mL), in a) 1 mL syringes and b) 2 mL syringes, Rx Only, Cantrell Drug Co., Little Rock, AR --- NDC 52533-010-45, UPC: 0100352533010453
- Distribution pattern
- Nationwide
- Recall initiation date
- Aug 21, 2015
- Initial firm notification
- Center classification date
- Jul 6, 2016