Methylprednisolone Acetate (PF) 40 mg/ml Injection, supplied in 1 mL, 2 mL and 5 mL vials, manufactured by New England Compounding Center, Framingham, MA

FDA recall notice · announced January 9, 2013 · New England Compounding Center

Class I FDA/FSIS Class I: reasonable probability that use will cause serious adverse health consequences or death.

The product

Methylprednisolone Acetate (PF) 40 mg/ml Injection, supplied in 1 mL, 2 mL and 5 mL vials, manufactured by New England Compounding Center, Framingham, MA

Reason for recall

Non-Sterility

Notes

Distribution: Nationwide
Lot/code information: All lot codes
Quantity: 9062 vials
Status: Terminated
Products in this recall event:
- Glycerin 100% PF, 1mL, 2 mL, and 5 mL vials, manufactured by New England Compounding Center, Framingham, MA (D-117-2013)
- Methylprednisolone Acetate 40 mg/mL Injection, Preserved, supplied in 5 mL and 10 mL vials, manufactured by New England Compounding Center, Framingham, MA (D-110-2013)
- Isovue 200 mg/mL PF and 300 mg/mL PF, Vials, manufactured by New England Compounding Center, Framingham, MA (D-119-2013)
- Omnipaque 240mg/mL PF, 300mg/mL PF, in 3 mL, 5 mL, and 10 mL, vials, manufactured by New England Compounding Center, Framingham, MA (D-122-2013)
- Saline 10% and 3%, in 5 mL and 10 mL vials, manufactured by New England Compounding Center, Framingham, MA (D-123-2013)
- Triamcinolone 10 mg/mL P, 40mg/mL P, 40mg/mL PF and 80 mg/mL PF in 1 mL, 2 mL, 5 mL, and 10 mL vials, manufactured by New England Compounding Center, Framingham, MA (D-124-2013)
- Lidocaine 1% PF, 2% PF, and 4% PF, in 1 mL, 2 mL, 5 mL, and 10 mL vials, manufactured by New England Compounding Center, Framingham, MA (D-121-2013)
- Betamethasone Repository 6 mg/mL PF Injection and Betamethasone Repository 6 mg/mL P Injection, manufactured by New England Compounding Center, Framingham, MA (D-112-2013)
- Betamethasone Sodium Phosphate 6 mg/mL P Injection, Betamethasone Sodium Phosphate 6 mg/mL PF Injection, Betamethasone Sodium Phosphate 8 mg/mL PF Injection, Betamethasone Sodium Phosphate 12 mg/mL PF (D-113-2013)
- Bupivacaine 0.25% PF, Bupivacaine 0.5% PF, and Bupivacaine 0.75% PF, manufactured by New England Compounding Center, Framingham, MA (D-114-2013)
- Methylprednisolone Acetate (PF) 80 mg/ml Injection, supplied in 1 mL, 2 mL and 5 mL vials, manufactured by New England Compounding Center, Framingham, MA (D-108-2013)
- Clonidine 100 mcg/mL PF, 1mL and 2 mL vials, manufactured by New England Compounding Center, Framingham, MA (D-115-2013)
- Lidocaine/Dextrose 5%/7.5% PF, manufactured by New England Compounding Center, Framingham, MA (D-120-2013)
- Methylprednisolone Acetate 80 mg/mL Injection, Preserved, supplied in 5 mL and 10 mL vials, manufactured by New England Compounding Center, Framingham, MA (D-111-2013)
- Dexamethasone Sodium Phosphate 4 mg/mL vials PF, 6 mg/mL PF vials, and 8 mg/mL PF vials, manufactured by New England Compounding Center, Framingham, MA (D-116-2013)
- Hyaluronidase 150 u/ml PF, 1 mL, 5 mL, and 10 mL vials, manufactured by New England Compounding Center, Framingham, MA (D-118-2013)
- Methylprednisolone Acetate (PF) 40 mg/ml Injection, supplied in 1 mL, 2 mL and 5 mL vials, manufactured by New England Compounding Center, Framingham, MA (D-109-2013)

Source: U.S. Food and Drug Administration public recall data. This page reports official records and is not legal, medical, or repair advice.