Meditech Laboratories recalls
FDA enforcement reports naming Meditech Laboratories, Inc as the recalling firm.
- Recall reports
- 7
- Class I (serious)
- 0
- Most recent report
- Apr 13, 2016
- Apr 13, 2016Formula 2 (Papaverine 9 mg, Phentolamine 1 mg, Atropine 0Drug · Meditech Laboratories, IncSuperpotent Drug: one ingredient was found to be above assay specification.Class II
- Apr 13, 2016Formula 4 (Papaverine 18 mg, Phentolamine 2 mg, Atropine 0Drug · Meditech Laboratories, IncLack of Assurance of Sterility: incomplete or missing data regarding production.Class II
- Apr 13, 2016Formula 9 (Papaverine 0Drug · Meditech Laboratories, IncLack of Assurance of Sterility: incomplete or missing data regarding production.Class II
- Apr 13, 2016Formula 1 (Papaverine 1Drug · Meditech Laboratories, IncStability Does Not Support Expiry: manufactured with an active ingredient that expired before the labeled Beyond Use Date.Class II
- Apr 13, 2016Formula 3 (Papaverine 20 mg, Phentolamine 3 mg, Atropine 0Drug · Meditech Laboratories, IncStability Does Not Support Expiry: manufactured with an active ingredient that expired before the labeled Beyond Use Date.Class II
- Apr 13, 2016Formula 0 (PGE 20 mcg/mL) Injection, 5 mL vials, Rx only, Meditech Laboratories, IncDrug · Meditech Laboratories, IncLack of Assurance of Sterility: incomplete or missing data regarding production.Class II
- Apr 13, 2016Formula 2 (Papaverine 9 mg, Phentolamine 1 mg, Atropine 0Drug · Meditech Laboratories, IncStability Does Not Support Expiry: manufactured with an active ingredient that expired before the labeled Beyond Use Date.Class II