Home / Recalls / Perry Drug Inc. / D-0260-2015

D-0260-2015 Class II Terminated

Recalled by Perry Drug Inc. — Overland Park, KS

FDA drug recall D-0260-2015 was initiated by Perry Drug Inc. on November 7, 2014 and is designated Class II. Reason for recall: Lack of sterility assurance;All lots of sterile products compounded by the pharmacy that are within expiry were recalled due to concerns associated with quality control procedures that present a poten… The recall status is terminated (terminated November 3, 2015). Affected quantity: 186 prefilled syringes.

Recall Details

Product Type
Drugs
Report Date
December 3, 2014
Initiation Date
November 7, 2014
Termination Date
November 3, 2015
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
186 prefilled syringes

Product Description

Methyl B12 25 mg/mL Inj., 10 Syringes, Compounded Rx, Perry Drug Compounding Pharmacy, Overland Park, KS --- NDC 88888-2014-37

Reason for Recall

Lack of sterility assurance;All lots of sterile products compounded by the pharmacy that are within expiry were recalled due to concerns associated with quality control procedures that present a potential risk to sterility assurance that were observed during a recent FDA inspection.

Distribution Pattern

Kansas and Missouri

Code Information

141006GG, 11/6/14; 141009FF, 11/9/14; 141014BB, 11/9/14; 141014BB, 11/14/14; 1410164, 11/16/14; 141021GG, 11/21/14; 141030DD, 11/30/14

Other recalls by Perry Drug Inc.

  • D-0267-2015 Class II — HCG Low Dose 10 IU / 0.1 mL, 5 Ml vials, Compounded Rx, Perry Drug Compounding P (November 7, 2014)
  • D-0269-2015 Class II — HCG 10,000 U/ 10 mL PF Inj, 8Ml vials, Compounded Rx, Perry Drug Compounding Pha (November 7, 2014)
  • D-0271-2015 Class II — Cyclosporine 0.045 % Sol PF, 12 mL bottle, Rx, Perry Drug Compounding Pharmacy, (November 7, 2014)
  • D-0275-2015 Class II — Sodium Tetradecyl SO4 0.3% Inj., 30 Ml vials, Compounded Rx, Perry Drug Compound (November 7, 2014)
  • D-0262-2015 Class II — Leuprolide 50 mcg/0.1 mL Micro Lupron Kit, 5Ml, Compounded Rx, Perry Drug Compou (November 7, 2014)
  • D-0263-2015 Class II — Phenylephrine HCl (100 mcg/mL syr) in 0.9% NaCl 1 mg / 10 mL, 3Ml Syringes, Comp (November 7, 2014)
  • D-0265-2015 Class II — HCG Low Dose 30 IU/0.1 mL, 5 Ml vial, Compounded Rx, Perry Drug Compounding Phar (November 7, 2014)
  • D-0270-2015 Class II — 2Ml HCG 10,000 U/ MB12 - 12,000 MCG/10 Ml Inj, 0.25ML (250IU), Rx, Perry Drug Co (November 7, 2014)
  • D-0268-2015 Class II — HCG 200 IU/mL Injection, 30Ml, 10 mL vials, Compounded Rx, Perry Drug Compoundin (November 7, 2014)
  • D-0261-2015 Class II — Tri-Mix (PGE-10MCG/PAP-30MG/PT 5Ml vials, Compounded Rx, Perry Drug Compounding (November 7, 2014)

FDA data resources